Posts Tagged Jobs

JOBS: September, 2019


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Please see some of my current opportunities below. All opportunities are for local (US based) candidates with valid work visa and require deep industry experience.  If you have an interest then please send an email (resume as an attachment) at wd under score darshana at hot mail or find me on Linkedin.

Clinical Trial Manager – San Jose, CA

Ideal experience: 8+ years experience in medical devices, ideally in neuromodulation.  Required, experience running clinical trials, and working with clinicians and medical centers.

Head of Regulatory – San Jose, CA 

Candidate must have 15+ years experience in bio/pharma industry. Experience working with biologics and taking a drug to market in the US and EU is essential.

Mechanical Engineer – San Jose, CA

The Mechanical Engineer is responsible for evaluating the current manufacturing processes and making design improvements to increase throughput, quality and reliability. This will be achieved by redesigning the current tooling and/or creating new tooling and equipment. The successful candidate will work independently and use sound judgment to deliver optimal manufacturing solutions. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Responsibilities

· Evaluate the current manufacturing processes /workflows and identify opportunities to realize improved product consistency and increased throughput
· Develop concepts and ideas for improving the exiting tooling as well as creating new tooling including semi-automation where applicable
· Take full ownership of tooling /fixture designs, conduct concept reviews, show proof of concept through prototyping coupled with supporting test data, coordinate with appropriate stakeholders for successful verification /validation, launch and documentation
· Create 3D models, engineering drawings and bills of materials
· Create comprehensive work instructions and manufacturing SOP’s
· Work closely with Process Engineering through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
· Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
· Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications
· Bachelor’s Degree in Mechanical, Manufacturing or related engineering fields
· 5-7 years hands-on experience in a manufacturing environment
· In-depth experience with complex mechanical /electromechanical design
· Extensive experience with precision mechanisms, pneumatics, fixtures /tooling and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
· Experience with creating engineering drawings, BOMs and product specifications
· Deep knowledge of material properties, heat treatment and surface finish
· Good understanding of DFM and lean manufacturing
· Excellent verbal, written, presentation and interpersonal skills
· Strong analytical and problem-solving skills
· Knowledge and/or hands-on experience with machine shop tools
· Deep knowledge of GD&T as well as proficiency with SolidWorks
· Prior experience with FDA regulations and ISO, cGMP, QMS standards
· Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications
· Knowledge /experience with electrical /electronics and PLC programming a big plus
· Knowledge /experience with plastic injection molding
· Experience with metal stamping, laser cutting and chemical etching
· Familiarity with cleaning and sterilization processes

Sr. Molding Engineer

Job Summary

The Sr. Molding Engineer is responsible for evaluating the current molding processes and leading the effort to increase throughput, quality and reliability. This will be achieved by redesigning the current tooling, creating new tooling /equipment as well as leveraging outside molding expertise. The successful candidate will become the resident expert in the areas of plastic injection molding and material selection. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Responsibilities

· Evaluate /characterize the current molding processes and identify areas of improvement while focusing on rapid manufacturing scale-up
· Work closely with the consumable engineering group and make recommendations for molding improvements such as use of alternate materials, parts consolidation, setup /process optimization etc. without compromising the design intent
· Conduct design concept reviews and present fresh ideas, new technologies and creative ways to take the current molding process to the next level
· Show proof of concept through rapid prototyping and supporting test data
· Take full ownership of all injection molding initiatives, coordinate with appropriate stakeholders from initial concepts through FAI, optimization, successful verification /validation, launch and documentation
· Work closely with Process Engineering through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
· Develop /optimize molding parameters and establish best practices in molding methodologies
· Work with external companies as needed to outsource injection molding activities and manage the vendors through all phases of the projects including user requirements, RFQ, vendor selection, concept & design followed by verification /validation
· Create comprehensive work instructions and manufacturing SOP’s
· Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications
· Bachelor’s Degree in Mechanical, Manufacturing, Plastics or related engineering fields
· 7-10 years of extensive, hands-on experience with plastic injection molding including but not limited to mold design, capability studies and process characterization /optimization
· Experience with rapid prototyping and multi-cavity plastic injection molding
· In-depth knowledge of material science /plastics properties and metrology techniques
· Experience with creating engineering drawings, BOMs and product specifications
· Good understanding of DFM and lean manufacturing
· Excellent verbal, written, presentation and interpersonal skills
· Strong analytical and problem-solving skills
· Prior experience with FDA regulations and ISO, cGMP, QMS standards
· Knowledge and/or hands-on experience with machine shop tools
· Deep knowledge of GD&T as well as proficiency with SolidWorks
· Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications
· Knowledge /experience with micro molding
· Knowledge /experience with DOE, SPC, FMEA
· Experience with metal stamping, laser cutting and chemical etching
· Familiarity with cleaning and sterilization processes

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JOBS: April, 2019


Job search. Loupe with jobs classified ad newspapers isolated on white. 3d illustrationPlease see some of my current opportunities below. All opportunities are for local candidates with valid work visa and require deep industry experience.  If you have an interest then please send an email (resume as an attachment) at wd underscore darshana at hot mail dot com.

Director of Pilot Manufacturing – San Jose, CA

Innovative medical device company located in San Jose, CA has an immediate opening for Director of Pilot Manufacturing.  This position will report to VP of Manufacturing Operations. This low volume production line is crucial to the company’s several ongoing preclinical studies.

Duties and Responsibilities
Lead day to day operations including injection molding, aseptic processing, capsule assembly, supply chain and other related activities; Develop detailed production planning, resource allocation, equipment maintenance, operator training etc.; work closely with product development, pre-clinical & clinical groups and quality in order to ensure achievement of targets & develop manufacturing plans & detailed production schedules; Manage inventory of raw materials & injection molded components; Manage human resources in pilot manufacturing; Maintain a strong commitment to quality; Comply with U.S. Food and Drug Administration (FDA) cGMP regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Requirements
Strong problem solving & analytical skills; Experience with use of statistical analysis & design of experiments for product optimization and validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation; Experience working with ERP systems & Broad GMP manufacturing background with Class III medical devices. Requires BS/MS in Mechanical, Electrical or Industrial Engineering and 15+ years’ experience managing & supervising manufacturing with a strong history of hands-on experience successfully transferring new products into manufacturing & Deep technical experience with manufacturing processes, design control and quality systems. Also required, strong problem solving and analytical skills; Experience with use of statistical analysis and design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test and test implementation; Experience working with ERP systems. Also essential is proven ability to coach & develop employees & develop effective cross functional relationships. This position requires interface throughout all levels & functions of the organization.

Director of Manufacturing Automation – San Jose, CA

This position requires a dynamic, energetic, self-driven, engineering leader with broad manufacturing engineering and automation experience & will report to VP of Manufacturing Operations. The Director of Manufacturing Automation will lead the development of fully automated manufacturing systems for all aspects of company’s disposable drug tablet manufacturing. This individual will be responsible for defining system requirements, developing proof of principle systems, developing timelines and managing budgets and providing direct oversight and management of automation suppliers as well as driving the implementation and validation of manufacturing lines. This individual will work closely with product development, manufacturing engineering and quality in order to ensure manufacturability, achievement of targets, and develop processes for optimum manufacturability.

Responsibilities: Define functional & detailed requirements & specifications for manu automation, including quality & regulatory requirements; Manage internal & external process automation programs, project schedules & budgets; Develop facility plans & specifications for manufacturing scale-up; Oversee installation & qualification of automated manu systems; Comply with USFDA cGMP regulations, (ISO), Company policies, operating procedures, processes & task assignments.

Requirements: Experience managing and leading complex cross functional projects involving, electrical, mechanical, quality aspects; Experience with mechatronics or automation engineering including machine, mechanism and fixture design; Strong problem solving and analytical skills; experience with use of statistical analysis & design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation. This position requires interface throughout all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome.  BS/MS in Mechanical, Electrical or Industrial Engineering & 15+ years’ experience managing an engineering group responsible for medical device development and manufacturing engineering with a strong history of hands-on experience is required. Also required Deep expertise in manufacturing automation for large scale manufacturing

 

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JOBS: August, 2018


Jobs search concept, Big red text word "Jobs" on white paper and Magnifying glass for jobs searchPlease see some of my current opportunities below. All opportunities are for local candidates with valid work visa and most require deep industry experience. Contract opportunities are posted at the bottom. If you have an interest then please send an email (resume as an attachment) at wd_darshana at hot mail dot com.  Please bookmark and keep checking here for updates on new opportunities.

Director of Assay Development – Palo Alto, CA

There is an exciting opportunity for Director of Assay Development in a VC backed startup based in Palo Alto, CA. Company is developing unique diagnostic platform to quantify salivary biomarkers for variety of diseases & physiological conditions. Candidate will work closely with electrical engineers to transform an oligonucleotide-based assay from optical measurements to electrical measurements on company’s proprietary platform & will play a key role in development of a high throughput assay for clinical R&D studies.

Qualifications: Experience in Molecular Biology, Biochemistry or related field w/ method development focus; data analysis & management skills; knowledge of oligonucleotide-based assay & application on biosensor based Field-Effect Transistor (Bio-FET) for developing in-vitro diagnostic device; Expertise in assay devt & validation methods, in design & prosecution of in vitro bio-recognition -based assays, and 3-5 years of hands-on exp in biomarker quantification using a variety of biophysical techniques.  Aptamer-related experience is advantageous.

Responsibilities: Manage team of lab researchers; Assist with data prep for analysis & reporting; Maintain lab equipment functionality; Track inventory, lab records, good lab practice (GLP) and safety; & Troubleshoot; Adapt assays to multiple platforms & optimize biosensing measurements; Validate biochemical assays & biomarker quantification; Develop & set-up biochemical & in vitro assay for high throughput platforms; Train team members; Provide technical information, experimental assay design & data analysis to team members.

Senior Scientist of Assay Application – Palo Alto, CA

There is an exciting opportunity for Senior Scientist of Assay Application, in a VC backed startup based in Palo Alto, CA. Company is developing unique diagnostic platform to quantify salivary biomarkers for variety of diseases & physiological conditions.

Qualifications: Experience in Molecular Biology, Biochemistry or related field w/ method development focus; data analysis skills; experience in protein and nucleic acid work using binding assays molecular interaction analysis (e.g. ELISA, SPR, FRET), protein microarray and surface chemistry. Aptamer-related experience is advantageous.  

Responsibilities: Assist w/ data preparation for analysis & reporting; Manage lab – inventory, records, equipment functions &  safety; Troubleshoot bench work; Assay Development, design & analysis; Work multidisciplinary team to design, develop & optimize assays & devices (optical and electrical); Adapt assays to multiple platforms & optimize biosensing measurements.; Validate biochemical assays for biomarker quantification; Facilitate technical communications between engineer and assay development teams.

Mechanical Engineer – Santa Cruz, CA

Company focusing on an array of brain computer interface devices to address a range of neurological problems has an opening for Mechanical engineer.

Head of Manufacturing Engineering – San Jose, CA

There is an exciting opportunity for Head of Manufacturing Engineering in San Jose, CA.  This is an exciting opportunity with high potential.

Responsibilities include,  implementing pilot manufacturing line, develop components & assembly manufacturing processes including materials science and selection, develop processes for injection molding, conventional & novel polymers, micro-product molding, converting &  sealing plastic films, micro-tablet compression, clean room processing & large molecule processing.

Required: BS in Engineering plus 12+ years of mechanical engineering experience in medical device industry. Any of the following, highly desired: Experience in consumer product medical device, pharmaceutical (transdermal and solid dosage), and combination product design, manufacturing process development, manufacturing equipment design and development, pharmaceutical and sterile device packaging development, 3-D metal and plastic product design, tooling design and fabrication, injection mold design and fabrication, CNC and g-code programming, production engineering management, maintenance management, manufacturing management, and project management and experience in new product launches through heritage product manufacturing.

Software Engineer – Santa Cruz, CA

Company focusing on an array of brain computer interface devices to address a range of neurological problems has an opening for SW engineer.  Embedded microprocessor experience and windows app experience is required. Highly preferred, design/coding experience for embedded systems with wearable/motor-driven devices.

CFO – San Jose, CA

There is an exciting opportunity for CFO for a company, in San Jose – CA. Found by a veteran leader the company focuses on disruptive drug delivery platform technology. 15+ years M&A and licensing deals experience in bio/pharma industry is required.

Director of Program/ Project Management – Santa Cruz, CA

There is an exciting opportunity for Director of Program/ Project Management for a company located in Santa Cruz – CA. This company is found by a veteran leader and focuses on an array of brain computer interface devices to address a range of neurological problems. Candidate is required to have 4+ years of medical device program or project management experience in electromechanical systems area.

Head of Regulatory – San Jose, CA

There is an exciting opportunity for Head of Regulatory for a company, in San Jose – CA. Candidate must have 15+ years experience in bio/pharma industry. Experience working with biologics and taking a drug to market in the US and EU is essential.

Design QA Scientist –  Pleasanton, CA.

Responsibilities: Support DQA Principal Scientists and Project teams; Review & approve documentation consistent with design control regulations; technical verification, risk; Assist DQA project team to assess completion of milestone deliverables; Assist in the review and development of high SOPs; Support audits/inspections; Other duties as requested.
Requirements: Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline, or equivalent combination of education and work-related experience.
Preferred: Job-related Professional License(s) or Certification(s) and 5 Years Development, Manufacturing and/or Quality Assurance experience under established quality regulations.

Clinical Research Associate II – California 

Responsibilities include, participate in design, planning, implementation and overall direction of clinical research projects; ensure compliance with the overall scientific study objectives;  work with international investigators and key customers as well; Travel to field sites to monitor studies; Receive general instructions; plans and prepare studies; Review study protocols, report manuscripts; Contribute technical & clinical operations expertise for these documents; Work with Data Management & Biostatistics staff on the design of documents and processes for the collection of study data from participating sites; Collect & maintain legal and regulatory documentation, as applicable; Assume responsibility for training & coordinating certification of study site personnel; Ensure accurate and complete study management/data collection and transfer to data management; Ensure site compliance with regulations and study protocol; Monitor the sites and provide technical assistance, as necessary; Assist, prepare and manages study timelines; Manage material logistics for the studies; Conduct reference material testing in-house. Organize investigator meetings, as necessary; Participate in Project Team Meetings; Keep informed of trends and developments in clinical research; Know &  effectively use the broad concepts of a particular field or speicalization to resolve problems of limited scope and complexity; Analyze alternative approaches to solve problems or devleop new perspectives & existing solutions. Bachelors degree in a scientific discipline or related field, or equivalent combination of education and work experience is required. Certificate of completion of sections 1 through 6 is required. Minimum 2-6 years of relevant clinical research experience and knowledge of regulations and guidelines is required.

Clerk – San Jose/ Santa Clara, CA

There is an opportunity for a Clerk in a biomed company, located in San Jose/ Santa Clara, CA area.

Responsibilities: Follow standard operating procedures to enter orders for high complexity clinical lab tests; Be responsible for efficient and accurate entry of customer and patient demographic data, clinical information, test request information and physician information; Review, understanding, and executing customer-specific requirements for order entry; Create service requests in CRM system to document issues and work closely with client service team to resolve and escalate incomplete or unclear order issues; Check work of others to ensure order entry quality; Troubleshoot problems & assist employees with process questions; Fax requests to customers to resolve unclear orders; Run queue reports to ensure daily tasks are completed; Assist account set up administration; Act as training resource for department employees; execute process improvement recommendations; Retrieve forms from lab; Escalate issues to appropriate internal resources; Interact with Finance team to provide patient billing information in a secure manner.

Skills: 2+ years experience working in the clinical laboratory, medical, order management, or related field; Experience using Customer Relationship Management (CRM) Software (e.g. NetSuite, Salesforce.com), laboratory information systems. Microsoft Office Suite a plus. Must be able to follow laboratory procedures and must adhere to the laboratory quality control policies; Ability to identify & act on issues within an order that may impact customer satisfaction & test turnaround time; Must be able to type 45 words per minute with excellent accuracy; Must be able to lift up to 35 lbs.

 

Regards, Darshana

4088980000

 

Contract signed and sealed, pen, stamp, documents for signature, document folder iconCONTRACT OPPORTUNITIES 

RMD Biospecimen Scientist – Pleasanton, CA — 6 mo. contract

The BioSpecimen Management (BSM) Scientist position will facilitate the daily operations associated with providing the best-in-class simple biological solutions to customers. Biospecimen solutions include acquisition, characterization, and management of biological materials, and build of select panels fit for purpose for RMD research. Responsibilities include deliver simple, efficient solutions, facilitate receipt of shipments of human biological samples, verify sample integrity and data accuracy, process (centrifuge, aliquot, and pool) samples, consolidate inventory, retrieve and distribute samples, maintain inventory of supplies and ships supplies and facilitate routine activities in the build of custom panels, in close communication with team members. Also includes, responsibility for the accuracy, quality, and timeliness of all assigned projects, tasks and related activities,  accontablity for electronic records management, use of validated systems, and keep supervisor informed of project status.  Requires, Associate degree or certification in Biological Science or related field, or equivalent combination of education & experience, experience handling biological samples, understanding of good laboratory, data and documentation practices, and experience with basic computer application.

Scientist 1 – Pleasanton, CA: 6+ Months Contract

This opportunity is with NGS workflow controls for the RSS assay development team that identifies and tests cutting edge reagents, technologies or protocols that are supporting the development of products in Oncology, Genetics, Infectious Disease and Automation/Sample Preparation. Areas of interest include short and long read sequencing technologies, low input and difficult sample preparation methods and creating integrated workflows. Candidates must be able to work in a collaborative, exciting, and fast-paced team environment.
Responsibilities: Operate & maintain equipment, interact with LIMS databases, complete projects in a timely fashion, research & development, and give presentations at weekly meetings. Additional responsibilities: Operation of different genomics analysis technologies such as next-gen sequencing, microarrays, real time PCR and ancillary equipment for quality control and validation; Develop, validate & apply methods for various genomics methods mainly focused on sequencing; Process include nucleic acid isolation and quantification, PCR amplification, library preparation, plate normalizations and Work with senior personnel, perform early development activity to create new workflows that are robust, cost-effective and time efficient; Collaborate with R&D to transfer new assays and methods to automation platforms; Work closely with IT group and instrument vendors to develop and implement automated workflows; Accurately and consistently record experimental methods, materials & results in electronic laboratory notebooks; Analyze data, evaluates results, form conclusions, and determine future experiments; Present findings or comprehensive project status reviews at internal/external seminars/meetings; Apply advanced technical writing & graphical skills to produce reports & documents; Prepare summaries, reports, presentations, manuscripts, etc.; Present early development work including scientific background information & project updates at internal staff meetings and at cross-functional team meetings; Determine all chemicals, reagents & supplies needed for a project; develop a strong knowledge of all related third-party vendors and their technologies and products; Establish and maintain productive relationship with personnel in development; orient & trains new Research Technicians & peers.
Requirements:  Strong Molecular Biology background or Biochemistry or Immunology background with strong knowledge of Molecular Biology;  Experience performing next-generation sequencing methods (Exome, whole genome, RNA sequencing) a plus; Bachelor of Science with a minimum of 2 years of lab experience.

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Tale of two Americas influencing #Election2016 & Open Letter to Hillary Campaign


Here’s something to think about… the country is soooo divided that Americans are living two distinctively different realities; it is almost like they are living in two different nations.

America 1

Imagine that you live in the Appalachian mountains off of Virginia or Ohio.  Jobs in mining and manufacturing that were once plentiful are gone and no one has offered you re-training to operate in a different reality that has been emerging.  Opioids & alcohol are easily available to dull your pain (in fact, in parts of Ohio, first time more people are dying from opioid addiction than natural causes).  You see yourself as having no future; the best is behind you. You are enormously proud of your heritage, hard work ethic, and your religious values.

Church used to be your anchor but now church attendance has fallen; you have no anchor. You just want someone new at helm in this country, to shake things up – you don’t care how or who it is as long as the person talks to you in a language you understand and holds someone; an outsider responsible for your plight. Your current reality is so painful that you believe you once lived in a phenomenal nation, and you are losing it to outsiders who steal your jobs. Perhaps you don’t see many immigrants where you live, but you hear statistics of jobs being offshored, terrorists rarely target your geographical areas and you don’t often see women in hijabs but you hear about terror attacks when they happen and it scares the s*&^ out of you. Lowering or raising federal minimum wage has no impact here because there is no economy, no jobs. If someone tells you they will build a wall to keep immigrants out then it resonates with you.  If someone promises to bring back outdated mining jobs back, you are filled with hope.

America 2

Now imagine  you are living in a place like Silicon Valley in California, a place on the cutting edge of innovation.  There is a different social and economic reality.  You work with Muslim engineer, Chinese American scientist, Mexican American patent attorney, Iranian American realtor and your child’s teacher is lesbian.  These people are not aliens but your next door neighbors and share similar interests and values, as you.  Price for 2 BR condo in newly built (and fraught with problems), millennium towers in San Francisco costs around $2M and when economy tanked in 2009 (right after George Bush left office), California was hit harder than Ohio and Indiana.  The number of people filing for bankruptcy protection in the first quarter of 2010 ranked California at number one for bankruptcy protection. Right after Florida and Nevada, California also had one of the highest foreclosure rates with 1 in every 192 houses being foreclosed.

I can personally vouch to the impact of extremely high unemployment, while living in a state where everything is more expensive.  Both my businesses died.  I offered recruitment and soft skills training, but no one was hiring and no one had budget for soft skills training.  In 2009, I made less than $10,000.  I sold my house and while my business continued to remain in a nearly dead mode, in 2010 and 2011, I pounded the pavement for hourly jobs at Starbucks etc. for which I was always considered overqualified.  But California is back in business and so am I; better than ever before.

How did California do it?  I think California did it by leveraging the global trends and with a unique blend of cutthroat captialistic competition and compassionate socialism.  Corporations may not be people but both companies and people in CA exhibit this blend of competition and compassion.  I have some more thoughts on this and if I am not distracted by other things, I may study this more and write another blog.  But for this post, I want to focus on what is required of a political leader to bring the two Americas together. 

Open letter to Clinton Campaign

Henceforth, Ms. Clinton must maintain a laser sharp focus on issues that matter in the swing states.  All focus should be solely on large percentage of undecided voters who swing back and forth between Trump and Hillary.  Stop talking about how racist Trump is or that he is adhering to Alt-Right.   More people learn how racist he is, more votes it is getting him. Trump’s entire candidacy is based on inciting hate and division and taking his message to the masses is only enabling him.  Besides, he has so much air time, everything he does and says is covered.

While American women would largely care for issues like equal pay for equal work, do not focus on sexism in Trump campaign.  In California, I saw ads targeting women, with mention of Trump’s abominable remarks denigrating women.  But California is tuned in already,  In the swing states, there are likely to be more women in committed relationships and more than right to choose and equal pay, they care more for jobs for their husbands.  Still for many, it is a man’s serious and primary responsibility to earn a living.

Do not mention immigration.  Trump has made entire immigration dialog in the country about sound bites (big wall, beautiful wall, Mexico will pay for it, deporting etc.) and more confident and more racist his sound bites, more they are striking a chord.  He effectively created an environment of fear where soundbite solutions are very appealing.  I don’t believe Ms. Clinton can give any effective soundbites on immigration.  That is simply not her style and people are not in the mood to listen to logic on this issue.

Do not mention environmental issues.  While this has been President Obama’s crowning achievement, it does not figure in top 10 priorities when you put it on Maslow’s hierarchy of needs.  Americans are generally more present oriented but are certainly focusing squarely on short term and immediate benefits during this election season.  The more Trump talks about how things will change on November 8, less concerned people are about benefits to future generations.  

Also, do not focus in the debate on Trump’s lack of foreign policy experience.  Americans often care little about foreign relations.  President GHW Bush made great strides in foreign relations and he got little credit for it.  Besides Trump scored a victory looking Presidential in Mexico.  More than that, no one cares.

Image result for maslow's hierarchy of needsThink of Maslow’s hierarchy of needs that goes from fulfillment of basic needs and only after they are satisfied, it progresses to focus on social needs.  When people’s basic needs of healthy food, clean water, and safety are not satisfied, focusing on social issues like women’s rights, race relations, immigration, pay equality, and equal rights for LGBTQ, are a luxury they can’t afford.  While Trump may be trigger happy to get access to the nuke button, for America 1, it does not feel like a looming disaster; instead, it enhances their feeling of safety.

Here are the issues that Clinton campaign should singularly focus on.  

Focus on JOBS

Image result for jobsForget all incredible and horrific things said and done by Trump that make him unfit to be the President. Stay singularly focused on jobs and the economy and his lack of concrete plan to create jobs.  In his post convention interview with George Stephanopoulos, Trump was questioned about jobs.  See clip below at 11 minutes, where Trump when asked why he brings in people from overseas to work at Mara Lago resort in Florida, he tried to duck the question by taking talking about other companies offshoring jobs and Stephanopoulos keeps bringing the discussion back to his issuing almost 500 offshore visas since 2010 and Trump deflects it again saying everyone does it because they can’t find American workers.  Hummm, they can’t be re-trained for low level jobs then how is he going to pressure Samsung and Apple to bring skilled jobs outsourced to Indian and Chinese engineers at fraction of the cost, back to America?  Use this clip with Clinton’s concrete plan to continue to create job growth in America.  This is not a sensational piece of news that elite media (largely favored by America 2) will play over and over but you must capitalize on.

http://abcnews.go.com/ThisWeek/video/donald-trump-41028199

Respect & concrete benefits to America’s Veterans

Image result for war veteransAmerica owes to our veterans.  But that sincerity must be expressed with something more tangible than “America loves you and is deeply grateful to you for your service”.  If one vet feels strongly enough to give away his purple heart to Trump then that is one too many vets disillusioned, and whom we must re-engage with.  Our vets must have certain level of job security, access to constant retraining, access to healthcare, including easy access to mental healthcare.  There must be early intervention before PTSD takes an enormous toll on their lives and the lives of their loved ones.  Talk about how Obamacare has enabled easier access to healthcare for so many people.

Access to mental healthcare and PTSD treatment

Image result for PTSDTrauma has become a significant part of modern life.  It is not only our vets who need access to treatment for PTSD, but also foster care children who are often shuttled around from family to family, from one location to another.  Children who witness domestic violence, often suffer from PTSD, while their needs may be completely ignored at home and outside.

Concrete plan to deal with opioids and other drugs

 Image result for opioid addictionAs mentioned above, in parts of Ohio, first time more people are dying from opioid addiction than natural causes.  Obama administration and FDA has been deeply concerned about escalating use of opioids and other drugs but how frequently do we hear from Hillary campaign about the plan that is in process?  For instance, the Obama administration is making it easier for doctors and law enforcement to use anti-addiction drugs.  FDA is putting in place steps so that companies seeking approval of any new opioids, must include abuse-deterrent properties and appropriate labeling. But more importantly, there are concrete steps in place to deal with current trends of opioid abuse, including additional training to prescribers on pain management and safe prescribing, encouragement for abuse deterrent formulations, make naloxone more easily available to treat opioid overdose, and encouraging new class of pain medicines without the same risks as opioids.  Ms. Clinton must relentlessly address opioid abuse and significant strides being made under Obama administration to counter that.  

Finally, I humbly suggest that Hillary campaign and the media stop playing over and over and over Trump soundbites that show his racial, gender and other biases – contrary to people being turned off by such bigotry, in the climate of fear he has created and the foundation of hate he has laid, his bigotry gives people a feeling of safety and hope. Considered dialog detailing the history of events and people as done by Rachel Maddow and others and late night shows (Colbert, Noah, Bee, Oliver and others) that point out ridiculous aspects of Trump messages with humor, are however excellent.

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JOBS – June, 2016


All US based opportunities require valid US work visa and prior experience in biomedical industry.  Most of my current needs are in engineering and all engineering opportunities require medical device experience.  I have added some other opportunities in science, sales, BD etc.

I will be adding more opportunities.  If interested in any opportunities below, please send me an email (resume as an attachment) at wd_darshana at hot mail dot com and include position title in the subject line.  Please include in the email, how well the description matches your background and where the gaps are, if any.  All leads or referrals are greatly appreciated.

Director of Engineering – San Jose, CA
(Medical device implantable experience and hands-on engineering passion required).

Automatic Test Equipment Engineer – San Jose, CA
Immediately available.  Requires medical device experience. Send in resume ASAP.

Manufacturing Quality Engineer – San Jose, CA
Immediately available. Please send in resume ASAP.

Biochemist – San Jose, CA
Requires MS with 6+ years experience or PhD with 3 years experience in Biochem, Molecular Biology or related.  Immediately available, send in resume ASAP, if interested.

Quality Assurance Manager – San Jose, CA


Senior Manufacturing Engineer – San Jose, CA


Manufacturing Technician – San Jose, CA


Senior Mechanical Engineer – San Jose, CA

Biologist – San Jose, CA
Software Sales – San Jose, CA
Seed stage company offering a suite of subscription based software products, supported by cloud infrastructure, has an exciting opportunity for software sales professional, to join as member of the core founding team.  Although at pre-funding stage, the company is already generating revenues, with massive and growing database of products that can help scientists make environmentally friendly decisions throughout product development life-cycle.  Extensive customer relationship experience is required.  Familiarity with SciFinder, Reaxys etc. is required.   

Engineering Technician – Mt. Laurel, NJ

An innovative medical device company focused on treatment of cardiac diseases, has an exciting opening for Engineering Technician, in Mount Laurel, New Jersey.

Requirements: BS in EE, 3+ years experience as R&D Electrical Engineering Tech/ Testing Engineer, Prior experience in strongly regulated industries (e.g. medical, defense etc.), Prior experience with reliability tests and assembly.

Job functions:
* Conduct all assigned tests, under the direction of a senior engineer.
* Implement reliability test programs and test setups to implement test protocols.
* Conduct and document test protocols in component and system reliability, failure analysis, etc.
* Ensure compliance with regulations including QSR, ISO Standards and corporate policies.
* Specify and purchase components for test setups and prototypes.
* Procure and maintain engineering lab equipment in accordance with quality practices.

Senior Business Development Role – EU

Reporting To: Head – Global BD to manage all aspects of business development across the CRO portfolio of services; secure and retain business through professional, consultative & proactive sales activities directed at key decision makers.

Responsibilities:
Maintain knowledge of all appropriate cross-sell opportunities; Continued awareness of competitive activities, positioning & pricing; Work with regional & international counterparts to develop & close integrated opportunities; Analyze potential opportunities & develop sales plans for each target account; Develop in-depth knowledge of customer organization; Represent company at various industry conferences & trade shows; Prepare & lead sales presentation; Educate team in customer culture, operational needs/methods & sales techniques; Handle follow-up related to sale & drive completion of contract;  Maintain high visibility in customer organization; Monitor customer satisfaction; Record, plan & coordinate customer sales activities in CRM (SALESFORCE) system.

Requirements:  BS or MS in Life Sciences – PhD. preferred; 10+ yrs experience in BD / sales for CRO, CMO or related in life sciences; Ideally industry experience in combination of pharma or biotech in discovery research, CMC or commercial manufacturing technical roles; Solid understanding of drug discovery & development process; Track record of achievement in terms of sales goals; Experience working with international clients & colleagues; Ability to visualize & integrate company’s service portfolio across the drug development continuum;  Ability to cross-sell & credibly represent company services to clients; Ability to work from home-based office

Additional details: The position is located in EU.  Base pay: between 100,000 to 125,000 euros, car: 800 euros per month, VPP: 5% of base pay; Pension benefits: as applicable per country, Designation – Regional Director, BD

Analog Design & Embedded Systems Engineering Leader – San Jose, CA

Innovative, well funded bio-medical startup with disruptive technology has an exciting opportunity for analog design engineering leader, in San Jose, CA. Stock options, in addition to working on something truly exciting and life changing, would be a huge upside in this opportunity.  Requirements include, years of steady experience and passion for engineering problem solving, natural ability to take leadership role (MBA not required). This opportunity is immediately available and if you are engineering problem solver then it is one of the most exciting opportunities you may come across.  

Leads Engineer – Austin, TX or San Jose, CA

Requires BS in mechanical engineering, related to biomedical engineering and 10+ years medical device experience.  Highly desired, experience designing and developing medical products with implantable leads like cardiac pacemaker leads, proficiency in CAD, SolidWorks, and experience with MatLab, hands-on experience for fabricating prototype leads and related fixtures and tooling.

Responsibilities:   

  • Design and develop new conceptual leads in groundbreaking fields of medical devices.
  • Prototype lead designs and perform preliminary bench top testing
  • Develop processes for advanced lead designs
  • Develop, document, and implement test protocols for design verification and process validations
  • Design tooling for manufacture and assembly of implantable leads
  • Support in vivo and clinical evaluation of developed components

 

EMBEDDED SOFTWARE/FIRMWARE ENGINEER FOR MEDICAL DEVICES – Austin, TX or San Jose, CA

Requires: BS in Electrical or Software Engineering & 5+ years exp designing & developing embedded systems for medical devices; expertise in embedded C/C++, in optimization for performance & memory usage; exp developing apps that run a variety of OS/RTOS targets; working in structured environment w/ source control & bug tracking systems; exp developing low level device drivers for SPI, I2C, USB, LCD, ADC, DAC, exp with variety of CPU architectures (Arm Cortex M3/M4, TI MSP430 etc.; exp w/ board bring-up; effective use of hardware test equipment including logic analyzers, digital storage oscilloscopes, etc. Requires proficiency with Microsoft Office tools.

Responsibilities:
* Develop firmware for very low-power, battery powered systems consisting of a mix of analog, digital & RF circuitry in highly integrated, low power embedded designs
* Participate in design activities at architectural & implementation levels
* Design & implement error checking & fault handling, robustness & safety features
* Document software design & implementation
* Support V&V testing, work with V&V team to develop test plans & protocols
* Adhere to standards to help ensure compliance with FDA, ISO, AAMI & UL standards.

Director, Quality Assurance – Mt. Laurel, NJ
In the process of getting filled. 

 

Requirements include: Bachelors degree; 10-12 years experience in QA including medical device industry experience and supervisory/ management experience; & Good working knowledge of domestic & international requirements & regulations such as FDA, ISO, GMP etc.

Tasks:
* Work with contract manufacturer to ensure that devices are manufactured in compliance with US and international quality system requirements.
* Participate in product development teams on behalf of Quality Systems. Identify and resolve quality issues throughout product development process to assure successful audits and regulatory filings.
* Review all product complaints and ensure timely reporting of those events to domestic and international regulatory agencies as necessary.
* Schedule, conduct and assist in responding to internal audits , supplier audits and inspections.
* Maintain a functional CAPA system in compliance with applicable regulations
* Maintain ISO 13485:2003 facility registration in accordance with applicable standards.
* Provide guidance and supervision for Shipping/Receiving Clerk as it relates to completion of receiving inspections and other quality related functions.
* Ensure that the Quality Systems function is carried out in accordance with GMP and ISO directives.
* Review and revise quality system documentation to ensure compliance with domestic and international quality and regulatory requirements.
* Manage, supervise and train staff, oversee projects ongoing within departments, carry out departmental administrative duties.
* Schedule and complete timely management review presentations.
* Manage the document services function to ensure that quality systems documents, records and regulatory submissions are controlled.
* Manage product release and non-conforming product activities
* Maintain program to ensure adequate training of personnel on quality system documentation. Work with HR Department on companywide training activities.
* Ensure employees training on the Quality Systems Regulation and key international regulations and standards.
* Manage the program for handling product returns, returned product evaluations (and repair/rework, where applicable), complaints and customer feedback in accordance with internal policies and procedures.

Senior Clinical Research Monitor: Located anywhere (requires 80% travel)

Position Summary: Responsible for data quality & regulatory compliance at US clinical trial investigational sites. This responsibility is carried out by conducting on-site monitoring visits with Investigator & other research personnel.  Highly competitive salary.

Primary Responsibilities
* Orient site personnel to study protocol/procedures
* Monitor compliance to FDA Regulations & study protocol
* Monitor & promote compliance to local IRB reporting regulations
* Manage study site activities through frequent on-site visits
* Perform initial, interim & closeout study visits
* Communicate findings to investigators & study staff at the site
* Prompt reporting of compliance issues to in-house staff
* Follow-up on all outstanding issues to ensure each matter is addressed in a timely fashion
* Provide timely communication & written reports to the Clinical Affairs department after each monitoring visit

Additional Responsibilities
* Schedule on-site monitoring activities & travel in conjunction with company travel policies.
* May be required to supervise additional field monitors
* Up to 80% travel required.

Education and Experience Requirements
* This position requires a RN, BS, or similar degree (CRCC) with at least 5 years experience in monitoring clinical studies. The candidate must be very familiar with all FDA regulations governing IDE clinical trials.
* Experience in cardiac medical device related clinical trials
* Experience in clinical trial data management

Field Clinical Engineer (FCE) – Germany ( several locations: North Bavaria and Thüringen)

Requirements: BS in Engineering, Science or related; 5+years experience with use of invasive cardiovascular medical devices; knowledge of device-based cardiac rhythm & heart failure management; Prior experience working with clinical studies; Ability to quickly analyze & resolve clinical/technical issues; Frequent traveling to investigational sites, corporate offices, investigator meetings &  industry meetings.

Tasks:
* Develop a strong rapport with clinical sites by acting as consultants to support the site’s needs.
* Responsible for supporting all field-based activities at clinical sites.
* Drive enrollment by ensuring that investigational sites receive the necessary support in order to enroll, implant, and follow patients in a manner consistent with the clinical protocol.
* Support implant procedures and follow-ups at clinical sites
* Share clinical / technical experiences with other personnel in order to improve understanding of product behavior, improve product performance and product acceptance by customer.
* Communicate activities and issues at clinical sites with other company personnel
* Fulfill all administrative requirements including the collection of relevant technical data and completion of necessary documentation

Senior Electrical Engineer – Mt. Laurel, NJ – may be filled soon

An innovative medical device company focused on treatment of cardiac diseases, has an exciting opening for Senior Electrical Engineer in Mount Laurel, New Jersey.

Requirements: B.S. in EE; 5+ years experience as R&D EE in regulated industries (i.e Medical, defense, etc.); Applications development & PM experience; exp writing protocols, reports, regulatory documents; Understanding of patent applications & processes.  Exp in circuit design (Analog & mixed-mode circuits) & with digital signal processing algorithms, a big plus.

Tasks:
* Provide project leadership in product design & specifications, under direction of VP Product Development.
* Develop reliability tests programs &  setups to implement test protocols
* Work closely with vendors (i.e design subcontractors) on product requirements & specifications.
* Conduct design reviews & ensure compliance of design regulations including QSR, ISO standards and corporate policies.

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JOBS – November, 2015


Please see below some of my immediate opportunities. All opportunities are for candidates located in the United States only.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.

Research Associate/ Scientist – San Jose, CA
Innovative, well funded startup with novel drug-delivery technology has an immediate opening for research associate, in San Jose, CA.  
Requirements include, solid track record in bioanalytical assays.  Proficiency in HPLC, Elisa immunoassays, luminescence assays, fluorescence assays or related is required.  Experience in quantitative analysis, variability analysis in tissue and plasma, experience in pharmacokinetics, and experience in biologics a big plus.  Stocks and benefits make this a highly attractive opportunity to be involved in cutting edge technology, at grounds level.  

CLS Lab Manager – Santa Clara, CA

Minimum Qualifications:
The lab manager must possess an active, valid license issued by the State to perform high complexity testing pursuant to chapter 3 of Business and Professions Code or to practice medicine, osteopathy or podiatry pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties they are supervising; and– appropriate to the specialty or specialties for which they are consulting and, for the specialties of diagnostic immunology, chemistry, hematology, and microbiology, must–
(1) Have earned a bachelor’s degree in a chemical, physical or biological science or medical technology from an accredited institution; (CLS required)
(2) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty or subspecialty in which they supervise.

Duties and Responsibilities:
The lab manger shall be accessible to testing personnel at all times testing is performed by providing on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director.
The lab manager shall be responsible for ensuring that tests and examinations are performed in compliance with chapter 3 of the Business and Professions Code and Title 42, Code of Federal Regulations, Part 493 standards as published October 1, 1994, regarding clinical laboratories and–
(1) Be responsible for providing day-to-day supervision of high complexity test performance by a testing personnel;
(2) Be responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.
(3) Assure that all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications;
(4) Ensure that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning;
(5) Provide orientation to all testing personnel;
(6) Ensure proper training and competency assessment of all supervised laboratory personnel;
(7) Ensure that Proficiency Testing procedures are followed as specified in Proficiency Testing Procedure;
(8) Timely review of all data and programs specified in the Quality Assessment Procedure as authorized

Project Manager with strong hands-on engineering plus bio background – Milpitas, CA

This is an exciting opportunity with a huge potential upside in stocks in a very innovative company with unique drug delivery technology.  
Strong technical background plus background in pharma chemistry and 10+ years experience with microsoft projects is ideal.  Drug-delivery device experience, a big plus.   

Director of Quality Engineering – Milpitas, CA

There is an immediate opportunity for Director of Quality Engineering.  It requires 10+ years experience in implantable device.  Some pharma experience highly desired.  Experience in implementing QE systems, a great plus.  This is very exciting opportunity to be involved in multiple projects with huge upside, in stocks potential.  Requires engineering background.

Director of Manufacturing Engineering – Milpitas, CA

There is immediate opening for Director of Manufacturing, that requires 10+ years experience in implantable devices.  Experience with injectible drugs, pills highly desired.  Strong hands-on expertise in tooling is required.  This is very exciting opportunity to be involved in multiple projects with huge upside, in stocks potential (a once in a lifetime kind of an opportunity).  

Post-doc opportunity – San Jose, CA

There are opportunities for some excellent post-docs for a drug delivery company.  These opportunities are for candidates with recent Ph.D. in Biochemistry or related and interest in obtaining exciting industrial post doc opportunity with exciting startup.

Senior Biochem Scientist- San Jose, CA

More details will be posted soon.  Meanwhile, candidates with strong drug delivery experience, please contact me.

Senior Quality Engineer – San Antonio, TX

Key Responsibilities
* Lead Quality Assurance for R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE and related statistical design and analyses, GDT, design reviews, audits/compliance
* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation
* Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III implantables
* Implement productive relationships with R&D and manufacturing suppliers and partners
* Work in a matrixed organizational structure to support facilities in CA & TX.
* Educate colleagues and support in-house uptake and implementation of these systems organization-wide
* Support the following functions: o Regulatory Affairs o Intellectual Property
* Business and Commercialization, including due diligence documentation
* Implement documentation systems, including electronic systems, under the functional direction of QA Director
based in San Jose

Key Qualifications
* Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial drug-device
and Class III experience desirable. At least 10 years experience, >15 years desirable.
* Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE, CQM, CSSBB) desirable
* Grown QA organizations with a hands-on, leadership- by-example and team-oriented approach
* Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE • Supported multiple complex projects and start-ups
* Developed and implemented design controls, documentation, and design procedures, protocols
* Developed and implemented manufacturability, and related process flows and controls, and selected qualified vendors to manufacture Class II and III implantable devices
* Strong technical skills with demonstrated ability to provide hands-on solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator

Key Job Parameters
* Full-time position located in San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Senior Clinical Data Manager – Dublin, CA

Clinical Supplies Contractor – Dublin, CA

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Jobs – August, 2015


Please see below some of my immediate opportunities.  Post doc and contract opportunities are for candidates located in the United States.  But there are some new opportunities below that are located in India, for anyone wishing to do a stint in India, in very exciting, cutting edge multinational.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.

Post-docs – Engineering – ME, EE, Biochemistry, Pharmaceutical Sciences – CA & TX
Requires excellent and proven hands-on problem solving skills.

Immediate contract Engineering Opportunities – San Jose, CA

  • Electrical Engineering & Software
  • Analog Design
  • PCB Layout (FR4, Flex etc.)
  • ASIC Design
  • Embedded Systems
  • TI MSP430, ARM, Cypress
  • Software (Windows, Linux, C++, Android, iOS)
  • Sensors
  • RF Communications
  • Bluetooth, Wi-Fi, 3G, 4G, GPS
  • Antenna Design
  • RF Test Labs
  • Test Engineering
  • Test Hardware & Software

OPPORTUNITIES IN INDIA

Architect – MRI System and Signal Processing Development (Pulse Sequencing) – Bangalore, INDIA

SUMMARY
Job includes performing magnetic resonance imaging (MRI) system simulation & pulse sequence design for fast simultaneous MRI imaging schemes and developing MRI image reconstruction algorithms
Academic Requirements include: Ph.D. degree and 5+ years of R&D work experience or BS / MS degree and 10+ years experience,  Major in Biomedical Engineering, Bio-Information System Engineering, Computer Science, Optics Engineering, or related areas.

Required experience includes: 5 – 15 years experience in MRI signal acquisition and/or image reconstruction, Comprehensive understanding of MRI system and pulse sequence design.  Also required, knowledge in MRI system development, MRI signal acquisition & MRI image reconstruction.  Strongly preferred: Knowledge in Simultaneous/ quantitative MRI & Compressed Sensing MRI

Job responsibilities include: Developing ultra-fast MRI imaging technology, MRI system modeling, Pulse sequence design (signal acquisition), Image reconstruction algorithm development & Compressed sensing for MRI


Architect / TL / PL – Bangalore, INDIA

Requires 5-10 yrs exp in C, C++, (QT, Boost); image processing, visualization, algorithm development, signal processing, & UI development. Requires experience with tools like VTK, OpenGL, ITK, CGal, OpenInventor, OpenCV, OpenMesh ImageJ, DICOM; proven application development record in image processing & visualization; domain knowledge of MR (Stroke, Metastatis, Cartilege, Dementia related clinical applications); and experience working with clinicians for development of software applications.  C++ (QT, Boost, Design Patterns).

Visualisation Architect – Bangalore, INDIA

Requirements include experience & knowledge in:  C++ (QT, Boost, Design Patterns), Data Analytics, Algorithms, Image Processing, Visualization techniques.  Highly desired: Proven research record & high quality publications in image processing, visualization or related areas; experience in one or more of the following: VTK, OpenGL, ITK, CGal, OpenInventor, OpenCV, OpenCV, OpenMesh, SPM.  Academic requirements include: MS or Ph.D. in Computer Science or related with emphasis on visualization & image analysis & good software development experience. Experience in medical imaging applications in CT or MR is nice to have.

Roles and Responsibilities – Developing & supporting visualization platform, Clinical image processing algorithm development from concept to productizing, Integration of algorithm & development of end to end clinical application with the team, Support clinical collaboration with hospitals to do competitor bench-marking & validation of algorithms and clinical application and Support system integration & system verification issues for visualization platform & clinical applications.

R&D for Computed-Tomography Segmentation Algorithm Development – Banglore, INDIA

Job includes: Organ-specific segmentation technology development for computed-tomography (CT) clinical applications (image processing).
Requirements include: 5+ years experience in computed-tomography (CT) image processing, CT image segmentation, Feature extraction and Pattern recognition & Classification.  Also required: Specialized Knowledge in signal processing, digital image processing, probability & statistics, programming in C/ C++, MATLAB.

BASIC JOB RESPONSIBILITIES
1) Segmentation Algorithm Development including developing organ specific segmentation, reinforcing segmentation applications, and CT image processing.
2) Feature Extraction Algorithm Development including Lesion area enhancement and extraction
3) Technology Development Based on Computer-Aided Detection including Developing pattern recognition algorithms & Developing classification algorithms

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Jobs – July, 2015


.jobs -- Cut To The Chase

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I have new opportunities in California and Texas; many of them are in in engineering in Quality, Manufacturing, and Mechanical and other job openings in Biochemistry, Physiologist with animal surgery experience and in manufacturing and document control of drug delivery type of medical devices.  I will post details as and when I get full descriptions.  All opportunities are for candidates located in the United States.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.  See below a list of additional opportunities.

Post-docs – Engineering – ME, EE, Biochemistry, Pharmaceutical Sciences – CA & TX
Requires excellent and proven problem solving skills.

Clinical Trial Manager/Sr CTM – Asthma (12-Month Contract) – Berkeley, CA

Overview:  Responsible for managing the full scope of proper study conduct including, but not limited to, protocol development to final report, regulatory filing and/or publications, coordinating cross functional efforts in the administration and progress of Phase 1 to 4 clinical trials.  Additional responsibilities include trial start-up, conduct, and close-out activities in order to achieve program objectives and goals.

The incumbent will use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.  May determine methods and procedures on new assignments.  Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.  Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Responsibilities:
* Lead clinical trial project execution for asthma programs to ensure that trial timelines, costs, and quality metrics are met.
* Serves as primary contact for functional area representatives in managing protocol execution.
* Manage the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments.
* Forecast and oversee clinical supplies, e.g. study drug.
* Manage study milestones to ensure accurate tracking and reporting of study metrics.
* Oversee ongoing service provider management (e.g., CROs, IVRS, Central Labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
* Create and manage clinical trial budgets in collaboration with manager and the Vice President of Clinical Operations.
* May provide study-specific direction and mentoring to CRAs and CTAs.
* Collaborate with Clinical Quality Assurance to maintain quality standards in compliance with regulatory requirements/guidance’s and adherence to SOPs and ICH/GCPs; participate in ongoing process improvement initiatives.
* Manage adherence to ICH/GCP/local regulations.
* Participate in clinical operations initiatives and programs.
* Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
* Other duties as assigned.

Qualifications:
* Bachelor’s Degree with at least 5 to 8 years of CRA experience for the manager level with at least 1 year of staff management experience.  The senior manager level requires 10+ years of combined CRA and CTM experience and 3 years direct staff management experience is required.
* Experience in inflammatory diseases, specifically Asthma and/or Chronic Obstructive Pulmonary disease (COPD) is required.
* Excellent communication skills to effectively disseminate information within clinical as well as other functional areas as appropriate.
* Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
* Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
* Excellent organizational and negotiation skills.  Proven ability in creative problem-solving and possess sound judgment.
* Team oriented and collaborates effectively with the Clinical Operations study team, cross-functional team members, and external partners.
* Proficient computer skills, specifically with Microsoft Office Suite that includes Word, Excel, PowerPoint, and Outlook.
* Working knowledge of MS Project for development and update of clinical study timelines.
* The incumbent in this position must be able to remain in stationary position 50% operating a computer and other office equipment and needs to occasionally move about the office for meetings, to access files, and other office equipment.
* Willing to travel – anticipate up to 25%.

Senior Mechanical Engineer – San Jose, CA
12+ years of Class III medical device is required, with experience in machining, injection molding etc.

Biochemist – San Jose, CA

Senior Electrical Engineer – Austin/ San Antonio – TX
A company working on innovative range of products, has an immediate opening for senior electrical engineer with class III device experience.  Experience with closed loop, analog design hardware, microcontrollers, actuators  and ultra low power consumption circuit design highly desired.

Key Responsibilities
* Lead Electrical Engineering, primarily for long-term implantable drug delivery devices:
* on R&D- design and development of implantable and associated wearable and external hardware using mixed signal- analog and digital techniques, sensors and actuators and closed-loop control systems
* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation esp for implantable electronics
* Develop Class III implantable electronics to be compliant with regulatory and QA standards (FDA and ISO), as well as be power-efficient, reliable for multi-year operation and pass EMI/RFI, be hermetically sealed and packaged and interface with rest of electronics systems for developed products
* Establish reliable suppliers and partners for manufacturing
* Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment
* Document work output and use project and organizational documentation systems, including electronic systems
* Plan for and support existing and projected growth of the company.

Key Qualifications
* Designed and implemented electronics mixed-signal hardware, firmware and software for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. 10-15 15 years desirable
* Bachelor’s degree in Electrical Engineering or in an equivalent field required
* Led and grown EE groups with a hands-on, leadership- by-example approach
* Demonstrated working experience and accomplishments with electronics hardware and software- analog/digital, sensors/actuators. Developed, selected and qualified sensors for both implantable device function and for measuring physiological parameters
* Familiarity and experience with other implantable device components such as connectors, leads, cables, interconnects, headers, electronics packaging, communication protocols and standards. Real-time microcontroller programming a plus.
* Excellent and demonstrated grasp and use EDA tools: sensor/circuit design, simulation, layout. Hands-on re: circuit and system prototyping and development
* Developed and implemented manufacturability, and related process flows and controls. Selected and qualified vendors for manufacturing Class III implantable device electronics.
* Working knowledge of biomaterials, drugs, drug delivery, and mechanical technologies in support of multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator
* Supported multiple complex projects in a start-up environment: able to prioritize.

Key Job Parameters
* Full-time position located near Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Senior Mechanical Engineer – San Jose, CA

This is an exciting opportunity to work at grounds level with a veteran leader, in innovative drug delivery space.  Minimum 10 years of medical device experience is required.

Opportunities in Berkeley, CA

If you are interested in any of the opportunities below in Berkeley, CA then send me an email with resume and I will be happy to share more details.

BioChemist – San Jose, CA
Scientist I-III, Potency Assay Development – 6-12 month contract
Scientist I/III Protein Analytics (Contract 6-12 months)
Senior Manager / Associate Director, Regulatory Affairs (Clinical)
Director, GxP & Research Applications
Director, SG&A Applications (Finance, Supply Chain, HRIS, and Reporting Systems)
Director/Sr. Director Corporate Communication
Medical Writing QC Reviewer – 12 month contract (x2)
Clinical Trial Manager/Sr CTM – Asthma (12-Month Contract)
Copy Editor – 6-12 month Contract
Director/Sr. Director, Marketing
Laboratory Assistant
Vice President and General Counsel
Sr. Director, Quality Assurance – Commercial
Director/Sr. Director,Quality Assurance, Development
Specialist/Sr. Specialist/Manager – Quality GCP Compliance
Post-Doctoral Fellow (Senior), Analytical Development – Protein Analytics and Characterization

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JOBS – March, 2015


Please see below opportunities and send resume as an attachment to wd_darshana at hotmail dot.  My imminent openings are for Senior Electrical, Mechanical, Quality and Software Engineering and for Technician – all with strong medical device experience.  Please also notice contract opportunities at the end.  All US opportunities are for US based and local candidates.  Opportunities exist in China that are open to all and you can see description in my previous blog at http://bit.ly/15STeDw specific one is for Director of Analytical R&D in Suzhou, China. When sending a resume, please mention job you are interested in, in the subject line and in the email include a brief summary of how best the job description matches your background and where the gaps are.

.jobs -- Cut To The Chase

.jobs — Cut To The Chase (Photo credit: Wikipedia)

Senior Electrical Engineer – Austin/ San Antonio – TX

A company working on innovative range of products, has an immediate opening for senior electrical engineer with class III device experience.  Experience with closed loop, analog design hardware, microcontrollers, actuators  and ultra low power consumption circuit design highly desired.

Key Responsibilities
* Lead Electrical Engineering, primarily for long-term implantable drug delivery devices:
* on R&D- design and development of implantable and associated wearable and external hardware using mixed signal- analog and digital techniques, sensors and actuators and closed-loop control systems
* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation esp for implantable electronics
* Develop Class III implantable electronics to be compliant with regulatory and QA standards (FDA and ISO), as well as be power-efficient, reliable for multi-year operation and pass EMI/RFI, be hermetically sealed and packaged and interface with rest of electronics systems for developed products
* Establish reliable suppliers and partners for manufacturing
* Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment
* Document work output and use project and organizational documentation systems, including electronic systems
* Plan for and support existing and projected growth of the company.

Key Qualifications
* Designed and implemented electronics mixed-signal hardware, firmware and software for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. 10-15 15 years desirable
* Bachelor’s degree in Electrical Engineering or in an equivalent field required
* Led and grown EE groups with a hands-on, leadership- by-example approach
* Demonstrated working experience and accomplishments with electronics hardware and software- analog/digital, sensors/actuators. Developed, selected and qualified sensors for both implantable device function and for measuring physiological parameters
* Familiarity and experience with other implantable device components such as connectors, leads, cables, interconnects, headers, electronics packaging, communication protocols and standards. Real-time microcontroller programming a plus.
* Excellent and demonstrated grasp and use EDA tools: sensor/circuit design, simulation, layout. Hands-on re: circuit and system prototyping and development
* Developed and implemented manufacturability, and related process flows and controls. Selected and qualified vendors for manufacturing Class III implantable device electronics.
* Working knowledge of biomaterials, drugs, drug delivery, and mechanical technologies in support of multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator
* Supported multiple complex projects in a start-up environment: able to prioritize.

Key Job Parameters
* Full-time position located near Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Senior Mechanical Engineer – Austin/ San Antonio – TX   &   San Jose, CA

A company working on innovative range of products, has an immediate opening for senior mechanical engineer with class III device experience at San Antonio, TX location and at San Jose, CA location.  See details below.

Key Responsibilities
* Hands-on support of Mechanical Engineering, primarily for long-term implantable drug delivery devices:
on R&D- design and development of implantable leads, cans, headers, and overall packaging and assembly of dynamic sensors, actuators, electronics and batteries for long-term (multi-year) use. Develop surgical tools and accessories for implantable systems.
* Manufacturing including materials (plastics, metals) and parts/system selection and qualification, process development: qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation especially for implantables
* Develop Class III implantables from all aspects of Mechanical Engineering to be compliant with regulatory and QA standards (FDA and ISO) including development and implementation of test fixtures and protocols
* Establish reliable suppliers and partners for manufacturing
* Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment
* Document work and input into project documentation systems, including electronic systems
* Plan for and support existing and projected growth

Key Qualifications
* Designed and implemented long-term active implantable medical devices. Combinatorial device and Class III experience desirable. At least 10 years experience, >15 years desirable
* Bachelor’s degree in Mechanical Engineering or in an equivalent field required
* Led and grown ME groups with a hands-on, leadership- by-example approach
* Demonstrated working experience and accomplishments with implantable plastics and metals for connectors, leads, cables, interconnects, headers, electronics packaging, sensors/actuators, and batteries.
* Excellent and demonstrated grasp and use of ME computer-based tools and techniques: SolidWorks, FEA (thermal, strength/structure), 3-D modeling and printing
* Developed and implemented manufacturability, process flows and controls, and selected qualified vendors to manufacture Class III implantable devices using prototyping manufacturing as well as for mass-manufacturing
* Working knowledge of biomaterials, drugs, drug delivery, and electronics technologies and working on multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator
* Supported multiple complex projects in a start-up environment: able to prioritize.

Key Job Parameters
* Full-time position located near Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Senior Software/ Algorithm Engineer – Fremont, CA

A company providing innovative diagnostic & therapeutic products &  services to enable interventionalists in providing superior patient care, has an immediate opening for Senior Software Engineer, in Fremont, CA.  Position Summary: This position will be responsible for developing the next generation of image processing algorithms for company’s revolutionary medical devices for cardiovascular business. Individual will participate in object-oriented software development projects using C++ and Qt for a Linux environment. Communicate effectively, as well as to present information to a group in a professional manner. Work cooperatively as part of a team with people from various facilities and technical backgrounds.

Primary Duties and Responsibilities:
Design, develop, and optimize next generation image processing algorithms
Perform lab research and algorithm testing
Develop multi-threaded software for desktop applications
Design code for maintainability and unit tests
Identify, evaluate and mitigate technical project risks
Support formal verification and validation process and participates in transfer of products from R&D to manufacturing
Team player working in a geographically distributed team
Accurately estimate time and resources for completion of specific features/project
Assist in maintaining ISO certification and 510(k) submission requirements

Qualifications & Required Skills:
Minimum BS degree in Computer Science, Computer Engineering, Electrical Engineering, Applied Math, Biomedical Engineering, or related field; Strong background in image processing; 5+ years of software development experience; Excellent coding skills in C/C++; Proficiency in MATLAB; Experience designing object-oriented and distributed software; System level architecture design experienc; Experience with source code management systems like GIT, SVN, Clear Case

Preferred
Experience developing software for medical device applications for user interaction and control
Experience with medical imaging algorithms like segmentation, co-registration, 3d reconstruction
Experience with python, DICOM, OpenGL graphics
Other: * Travel requirements are moderate. Travel to facilities would be about 2 – 3 days duration each trip with total travel expected to be less than 20%.

Please submit resume at wd_darshana at hotmail dot com, with answers to following questions in the email.  This is client HR’s requirement. 
Please provide information on your formal education:
Please describe your software engineering experience as it relates to design, proof-of concept, detailed design, code, unit and integration testing:
Please describe your experience utilizing UML modeling language, DiCom, MFC, BOOST, STL and C++ :
Do you have experience working Linux OS environment? If yes, provide more detailed information:

Senior Design Engineer with Embedded Hardware & Firmware Skills – Santa Clara, CA

A reputed contract engineering company has an immediate full time opportunity for  a Senior Design Engineer with Embedded Hardware & Firmware Skills.  A rounded individual is desired who has an interest and ability in a wide range of technologies.  The successful candidate will lead a group of engineers from time-to-time and may be required to act as the primary interface to the customers at times.  The company designs devices, firmware, and software for other companies and has a reputation for quick response with high quality work.  The person must enjoy working with customers and have good communication skills.  The person must work well on a team of high performing engineers.  The person needs to be organized.  The person must work well with others and be flexible as schedules and priorities change.

Technical requirements: Ten years of experience in embedded system design engineering is required.  Ability to supervise others is highly desired.  The person should have experience designing circuits with microprocessors from PIC to ARM, FPGAs, Bluetooth, and WiFi as well as experience with programming in C or C++ on these devices.  The person must enjoy learning and be able to learn quickly.  The ability to design and program FPGAs is desired.
This could be a work-at-home job, or work at the company site, in Santa Clara, CA.

QUALITY ENGINEER – Santa Cruz, CA

Summary:  Medical device design and manufacturing company, located near Santa Cruz, CA, focusing on custom injection molded plastic parts, has an immediate opening for Quality Engineer.  Position focus is on providing support in the development and maintenance of company’s quality systems, support activities related to the development and qualification of new product development for medical device components and assemblies as well as supporting existing products.
Responsibilities
* Write FMEAs, review and write protocols and reports for new products
* Ability to multitask on a variety of Quality System compliance and improvement initiatives in a hands-on dynamic environment and be involved with the design, procurement, validation and qualification activities including test, inspection and medical device contract manufacturing service processes.
* Responsible for the facility measurement equipment calibration and maintenance program.
* Collects, collates and analyzes manufacturing data for warranty and nonconformance to determine and report product quality trends.
* Conducts analysis of inspection and tests of a routine degree of complexity and provides recommendations accordingly. Develops quality control inspection requirements and techniques to achieve measured improvement. * Implements the Failure Analysis Process for internal and external nonconforming product to determine appropriate corrective action.
* Support Receiving, In- process and Final Inspection of various components and subassemblies for medical device products to support quality compliance and shipment goals as workload requires.
* Assist in the development and implementation of Quality System processes.
* Attend various product meetings with Engineering, Sales, Support, Marketing, and customers to address product requirements, customer concerns and training issues. Work toward and support Company/Department/Team goals including; QSR and ISO compliance, revenues, training utilization, customer satisfaction, and others as appropriate.
* Qualify and implement document changes involving product or process changes
* Coordinate the reporting, analysis, and resolution of material non-conformance incidences
* Provide support in the timely resolution of product complaints and/or safety issues
* Conduct quality audits and develop subsequent preventive action programs
* Assist Regulatory Affairs Department in the preparation of audits and reports for regulatory agencies.
* Perform Supplier Quality Audits and, as appropriate, Internal Quality System Audits; identify root cause of non-compliance and ensure timely/effective corrections and lor corrective preventative actions are implemented
* Drive effective root cause corrective action through internal and supplier surveillance and corrective action requests.
* Report MRB performance metrics and maintain corrective action database.
* Review and report in-process data from manufacturing processes and facilitate corrective and preventive actions

Requirements: 5 – 7 years’ experience in Quality, medical device, regulatory, and or a medical device manufacturing environment; BS in Bachelor of Science in Quality, Business, Mechanical Engineering, Engineering or related field; Certification, CQE, CQA a plus; Experience as an ISO Lead Auditor desirable; Must be able to communicate effectively at varying technical levels with a customer audience; Hands-on manufacturing experience in mechanical or medical device assemblies. CMM, MicroVu, Vision Systems Programming experience; Working knowledge of U.S. and international medical device regulations is desirable Working knowledge of desktop computer office software, Visio Tools, CAD software and e-mail is required; Excellent verbal and written communication skills; Flexibility to handle multiple tasks and meet timelines; Excellent analytical and problem-solving skills combined with a strong technical presence.

Senior Quality Engineer – Austin/ San Antonio – TX

A company working on innovative drug delivery technology has an immediate opening for senior quality engineer. Great opportunity to work at grounds level and grow into leadership role, in addition to the upside of stocks.

Key Responsibilities:
* Lead QA for: R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE and related statistical design and analyses, GDT, design reviews, audits/compliance; Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation
* Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III implantables
* Implement productive relationships with R&D and manufacturing suppliers and partners
* Work in a matrixed organizational structure to support company’s facilities, including the respective incubated companies, projects and technologies with an appropriate QA system for each segment
* Educate colleagues and support in-house uptake & implementation of these systems organization-wide* Support the following functions: Regulatory Affairs: provide appropriate documentation and materials to support filings for US and international trials and approvals; Intellectual Property: supporting documentation; Business and Commercialization, including due diligence documentation
* Develop & implement documentation systems for these business functions, including electronic systems, with help of to –be-hired Documentation Specialist

Key Qualifications
* Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. At least 10 years experience, >15 years desirable*
* Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE, CQM, CSSBB) desirable
* Led and grown QA organizations with a hands-on, leadership- by-example approach
* Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE
* Supported multiple complex projects and start-ups: able to prioritize.
* Developed and implemented design controls, documentation, and design procedures, protocols
* Developed and implemented manufacturability, and related process flows and controls, and selected qualified vendors to manufacture Class III implantable devices
* Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator

Key Job Parameters
* Full-time position located in Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Electro-Mechanical Technician – Fremont, CA

A company that develops advanced injection technologies to simplify the complexities of the cardiac cath lab, has an immediate opening for R&D technician.

Requirements
* 9 years of electromechanical technician experience
* 2 year Technical School degree in electromechanics or related field or a combination of education and experience
* 2 years of computer aided design experience
* 2 years experience directing and leading the work of others
* Problem solving skills with the ability to interpret drawings, schematics, and specifications
* Experience using CAD-3D Modeling
* Effective verbal and written communication skills
* Moderate level of computer experience including MS Office Suite and SolidWorks
* Demonstrated experience using a multimeter, soldering iron, oscilloscope, and spectrum analyzer
* High degree of organization skills and high attention to detail
* Ability to prioritize and handle multiple tasks
* Ability to work independently with limited supervision
* Proficient at specifying and evaluating electrical components based on performance, lifetime, and availability
* Demonstrated project management experience
* Demonstrated test report-writing experience

Preferred
* 4+ years of computer aided design experience, * SolidWorks Proficient, * Experience providing technical support to circuit board manufacturing assembly, * Demonstrated knowledge of and familiarity with embedded systems and RF electronics, * Product development experience in a federally regulated engineering environment (FDA, ISO), * Experience defining, writing, and conducting test plans and reports.

Job Description & Responsibilities
Performs specified electromechanical engineering support activities under the guidance of an Engineer or Technical lead related to electro-mechanical design of medical device technologies, product and performance testing, and continuous improvement of the product design. The position is responsible for design, fabrications, assembly, validation, and implementation of development products and fixtures to support the design transfer of products into manufacturing operations.

Primary Duties and Responsibilities:
* Designs fixtures and test methods for validating product design and performance. Responsible for managing the ordering and delivery of fixture components and items from vendors or the internal Model Shop.
* Executes testing and validation protocols, records and analyzes data, and provides written reports to engineering team.
* Supports Product Development efforts at early stages up to design transfer. Provides support to engineers throughout the implementation and development cycles.
* Performs hands on activities such as design validation, pre-production assembly, testing and other technical activities to assist in product development.
* Assists engineers in identifying and resolving hardware design issues. Diagnoses the cause of electrical failures of circuit boards and operational equipment.
* Uses Solid Works CAD system to sketch and design fixtures and devices ensuring form, fit and functional requirements are met. Responsible for basic analysis of design in partnership with an Engineer.
* Responsible for initiating documentation changes and providing redlines to maintain the product information structure. Communicates issues and opportunities to engineering department to ensure bill of material (BOM’s), prints, process, forms, records, etc. are relevant and up to date.

Technical Engineering Support:
* Partners with Designers and Engineer, to develop and improve products, designs, fixtures, and process activities in the interest of continuous improvement and establishment of a Lean environment.
* Initiates design changes and coordinates the change order process to release product per the company’s Quality Management system. Responsible to maintain the design and information structure for use in the ERP system and engineering data base (PDM) DB Works. e.g.; BOM’s, prints, process, forms, records etc.
* Implements changes and maintenance of PDM and CAD systems as required. Assists IT and Technical Documentation Writer in annual CAD system updates, user rights management, and data base management. Creates and edits DB-Works and Solid Works API programs.

IF interested, please send resume with answers to the questions below. The client will only accept resumes, if the questions are answered.
Describe your formal education:
Describe your experience working in medical device or a regulated environment.
Give an example of a work situation where you had minimal supervision and it was critical to work within a fluid or flexible environment.
Describe your experience with developing test fixtures and methods to evaluate a product and/or technology.
Describe your experience developing or using different types of CAD models (or Computer-Aided Design), electrical schematics, or other types of models. (New Q)
Give an example of a product and/or technology project where you had to apply both mechanical and electrical/electronic skills.

 

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JOBS – December, 2014


This is a photo symbolizing the job search in ...

This is a photo symbolizing the job search in today’s economy. Out of the darkness, there seems to be a ray of hope–but where? (Photo credit: Wikipedia)

The year is coming to a close and here is a last blast of opportunities.  Please note: With the exception of the opportunities in China, other opportunities are only for local US based candidates, with valid US work visa.  For the opportunities below, please send resume at wd_darshana at hot mail dot com.  Please indicate in the email how closely the job description matches your background and identify gaps, if any.  Also, indicate your current compensation and compensation expectations.  The opportunities are in the order of priority from most important fresh opportunities to others that are in the process of being filled.

Principal R&D Technician – Fremont, CA

A company that develops advanced injection technologies to simplify the complexities of the cardiac cath lab, has an immediate opening for R&D technician.

Requirements

* 9 years of electromechanical technician experience
* 2 year Technical School degree in electromechanics or related field or a combination of education and experience
* 2 years of computer aided design experience
* 2 years experience directing and leading the work of others
* Problem solving skills with the ability to interpret drawings, schematics, and specifications
* Experience using CAD-3D Modeling
* Effective verbal and written communication skills
* Moderate level of computer experience including MS Office Suite and SolidWorks
* Demonstrated experience using a multimeter, soldering iron, oscilloscope, and spectrum analyzer
* High degree of organization skills and high attention to detail
* Ability to prioritize and handle multiple tasks
* Ability to work independently with limited supervision
* Proficient at specifying and evaluating electrical components based on performance, lifetime, and availability
* Demonstrated project management experience
* Demonstrated test report-writing experience

Preferred
* 4+ years of computer aided design experience, * SolidWorks Proficient, * Experience providing technical support to circuit board manufacturing assembly, * Demonstrated knowledge of and familiarity with embedded systems and RF electronics, * Product development experience in a federally regulated engineering environment (FDA, ISO), * Experience defining, writing, and conducting test plans and reports

Job Description & Responsibilities
Performs specified electromechanical engineering support activities under the guidance of an Engineer or Technical lead related to electro-mechanical design of medical device technologies, product and performance testing, and continuous improvement of the product design. The position is responsible for design, fabrications, assembly, validation, and implementation of development products and fixtures to support the design transfer of products into manufacturing operations.

Primary Duties and Responsibilities:
* Designs fixtures and test methods for validating product design and performance. Responsible for managing the ordering and delivery of fixture components and items from vendors or the internal Model Shop.
* Executes testing and validation protocols, records and analyzes data, and provides written reports to engineering team.
* Supports Product Development efforts at early stages up to design transfer. Provides support to engineers throughout the implementation and development cycles.
* Performs hands on activities such as design validation, pre-production assembly, testing and other technical activities to assist in product development.
* Assists engineers in identifying and resolving hardware design issues. Diagnoses the cause of electrical failures of circuit boards and operational equipment.
* Uses Solid Works CAD system to sketch and design fixtures and devices ensuring form, fit and functional requirements are met. Responsible for basic analysis of design in partnership with an Engineer.
* Responsible for initiating documentation changes and providing redlines to maintain the product information structure. Communicates issues and opportunities to engineering department to ensure bill of material (BOM’s), prints, process, forms, records, etc. are relevant and up to date.

Technical Engineering Support:
* Partners with Designers and Engineer, to develop and improve products, designs, fixtures, and process activities in the interest of continuous improvement and establishment of a Lean environment.
* Initiates design changes and coordinates the change order process to release product per the company’s Quality Management system. Responsible to maintain the design and information structure for use in the ERP system and
engineering data base (PDM) DB Works. e.g.; BOM’s, prints, process, forms, records etc.
* Implements changes and maintenance of PDM and CAD systems as required. Assists IT and Technical Documentation Writer in annual CAD system updates, user rights management, and data base management. Creates and edits DB-Works and Solid Works API programs.

Quality Assurance Manager & Quality Engineer – North San Jose, CA
Quality Engineering background essential for both – more details with follow (feel free to send resume).

Document Control Technician – North San Jose, CA
Details with follow (feel free to send resume).

Director of Operations – North San Jose, CA
Experience running production lines, planning, project management from soup to nuts, people management, experience in quality, GMP, and class III device experience essential.  Full description will follow soon.

Analytical R&D Scientist – TX
Details to follow (feel free to send resume).

Asceptic Process Manufacturing Engineer – North San Jose, CA
Details will be posted soon (feel free to send resume).

Balloon Assembly Manufacturing Engineer – North San Jose, CA
Full description will be posted soon (feel free to send resume).

Engineering Technician with Machning Experience – North San Jose, CA
Description will be posted (am submitting resumes).

Bio Technician – North San Jose, CA
Experience running immunoassays & chemistry assays in a lab plus MS in relevant field required.  More details to follow (feel free to send resume).

Director of Product Portfolio Management – China

A leading biopharmaceutical company in China, with a goal to bring best products at local prices to Chinese populace, has an immediate opening for Director of Product Portfolio Management, in beautiful Suzhou, China. See details below. Compensation includes attractive benefits package + salary + stock options + an opportunity to work in state of the art facility & make real impact.

Requirements:
A candidate must have a Ph.D. degree in Pharmaceutical Sciences, Biology or related disciplines and over 15 years of industry experience (or equivalent) of developing biologics, drug products and new formulations for various therapeutic areas for China and international markets.
* Demonstrated records of leading domestic and international generic drug product development that resulted in recent regulatory approvals in China, US or Europe
* Broad knowledge and experience about biologic drug product development including strategies and approaches, medical and market needs, and regulatory requirements in China and other major markets
* Extensive network with leading researchers in the research institutes and the industry who are engaged in biologics and innovative drug product development
* Excellent written and verbal language skills for communication in both Chinese and English

Responsibilities
This position, based in Suzhou, China, will report to the CEO and be responsible for leading the Product Portfolio Management Department to develop and manage drug product development portfolio for the company. A successful candidate will lead the department to leverage internal and external resources, establish and progress drug product development portfolio in alignment with company’s short term and long term business strategies and objectives.

Additional Responsibilities
* Build and lead the department comprised of functions including patent search, intellectual propriety (IP), product selection, cost analysis, budget planning and project management
* Collaborate with the marketing, medical, regulatory departments and manufacturing facilities to gain in-depth understanding of business needs, regulatory constraints and manufacturing facilities and capabilities
* Lead to establish R&D strategies in alignment with corporate business strategies by fully considering medical needs and marketing trends in different therapeutic areas, business priorities, regulatory constraints and manufacturing facilities and capabilities.

Director of Analytical Research & Development – China 

A leading biopharmaceutical company in China, with a goal to bring best products at local prices to Chinese populace, has an immediate opening for Director of Analytical Research & Development, in beautiful Suzhou, China. See details below. Compensation includes attractive benefits package + salary + stock options + an opportunity to work in state of the art facility & make real impact.

Requirements:
* A candidate should have a Ph.D. degree in analytical chemistry or related disciplines with more than 10 years of industry experience (or equivalent) in providing analytical support to API and drug product development.
* Demonstrated records of leading analytical development that resulted in recent regulatory approvals in China, US or Europe
* Extensive experience of establishing and implementing analytical control strategies (including specifications) and stability studies for innovative or generic drugs developed using scientific and systematic approaches
* In-depth understanding and practical experiences of implementing and operating under quality and regulatory requirements supported by successful passing GMP inspection and pre-approval Inspection
* Excellent written and verbal language skills for communication in both Chinese and English

Overall Responsibilities: This position will report to the Vice President of Quality, & be responsible for establishing and leading the Analytical R&D to support biological API, drug product and new formulation development for technology transfer, clinical supply manufacturing, domestic and international product registration and commercial manufacturing. A successful candidate will lead the department in collaboration with internal stakeholders and external partners to ensure drug product project progression, cost control and timeline while all technical, quality and regulatory expectations and requirements are met.

Additional Responsibilities:
* Establish and lead the Analytical Research and Development Department responsible for providing analytical support to API and drug product development portfolio
* Establish analytical laboratories by designing proper layout, equipping with analytical instrumentation necessary to support API, product and process development
* Build analytical teams with strong expertise to support API development including raw material testing, in-process control, API solid form and particle size control, and release testing as well as drug product development including excipient testing, in-process control and finish product release testing for conventional dosage forms (e.g., oral solid IR and MR, sterile products) and innovative drug delivery systems
* Implement standard operating procedures (SOPs) and best practices for analytical development activities and ensure technical, quality and compliance requirements are met
* Direct and ensure analytical project teams establish analytical control strategies, develop, qualify and validate analytical methods for API and drug product development, clinical supply manufacturing, registration and commercial manufacturing
* Project, identify, allocate and manage internal and external resources (including academic research institutes, CROs, and parent companies) needed to deliver analytical support to meet established timeline within budget
* Support regulatory submission, query responses and pre-approval inspections to ensure regulatory approvals
* Establish a good working relationship with regulatory agencies in China and other major markets. Participate and lead technical based engagement such as dialogues with regulatory agencies through industry associations
* Initiate and lead technical collaboration with external partners (including academic research institutes, CROs, and parent companies) to develop new analytical technologies or novel applications
* Provide technical assessment including due diligence to support business development opportunities
* Develop a training program for the department to ensure all essential training needs for technology, quality and compliance are provided

Director of Quality Assurance – Suzhou, China

A leading biopharmaceutical company in China, with a goal to bring best products at local prices to Chinese populace, has an immediate opening for Director of Quality Assurance, in beautiful Suzhou, China. See details below.
Reports to Corporate Legal Representative (as specified by law in China)
Direct reports – Manager of Documentation

Requirements: BS and 10+ years experience in QA for monoclonal antibodies & other recombinant proteins. Should be technical expert in QA & cGMP compliance including technical issues related in the manufacturing, testing & characterization of recombinant proteins; must have technical background to evaluate issues based on the science and not rely solely on historical precedent; must have experience in development of biopharmaceutical products for registration in the US and Europe, including experience in the preparation of documents that support regulatory submissions. Chinese language skill is a plus.

Responsibilities: Oversee Quality Assurance functions pertaining to release of drug substance & drug products; responsible for the controlled document system and the documents within the system including batch records, SOPs, validation records & other controlled documents; translating goals into action plan. Also responsible for staff development including cGMP training; ensure compliance with company policies & maintain safe work environment.

 

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