Posts Tagged Biology

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.

, , , , , , , , , , , , , , ,

Leave a comment

CellWorks & BioImagene – Successfully bringing IT innovation to Life Sciences


With technology advancement and ability for wider application, interesting things are happening on the boundaries of disciplines, rather than within a given discipline.  Internet and Sofware technology advancement along with fresh “can do” attitude, has infused new energy into Biotech.  CellWorks and BioImagene are two examples, where software stalwarts and serial entrepreneurs like Pradeep Fernandes and Mohan Uttarwar brought innovation to be applied to the healthcare industry.

At www.eppicglobal.org event on August 5, 2013, Fernandes and Uttarwar discussed what motivated them to gravitate towards life sciences, after a career in IT and software, the opportunities and challenges in making this transition, and the lessons learned in the process.  They both said, their ignorance about regulatory challenges was a bliss because had they been previously aware of the regulatory hurdles, they might have doubted the whole enterprise.  Both of them encountered a problem in healthcare and realized there was a hole in the market, in addressing the problem.

Fernandes’s wife got thyroid cancer and while making the rounds of the hospitals and doctors, they came to realize that despite existence of huge amount of big data and large quantities of freely available published data, few people were connecting the dots for efficient diagnosis and treatment. Serendipitous discussions with his good friend and colleague (an engineer) and his wife, a PhD in biology, led them to investigate whether modeling can be used to connect the dots and predict biological effects computationally, bridging two disciplines. R&D costs in big pharma are skyrocketing and it costs about $1to $4 B per drug, before it is available for commercial use.  During the development stage, 40% of drugs fail due to lack of efficiency (that is, they simply do not work), and other 40% fail due to toxicity (bad side effects), said Fernandes.  In the long chain of drug development, Fernandes focused on Biology.  “If the biology is wrong, no amount of chemistry is going to make it safe or potent”, said Fernandes.  The challenge is that despite technology advancement, drug development process remains unchanged and key decisions regarding validation of drugs happen very late in clinical trials.   Bringing the advancement in computational algorithms and informatics, his company, CellWorks extracts information from large data sets and also predicts information through abstraction modeling and simulation.  With an ability to model how pathways interact to represent disease phenotypes, CellWorks has further refined their approach to design therapies with novel mechanism of actions.  Greatly reduced cost and time for drug development has enabled CellWorks to advance their lead candidates for several indications from early design stage to validated animal efficacy studies in very short time period.  CellWorks closed $10M Series B round, at the end of 2012.

Origins of Mohan Uttarwar’s company BioImagene also lie in his keen notice of a problem in the market place that was not addressed.  One of the close family friends had cancer and in accompanying the individual to the medical facilities, he noticed that the medical establishment used glass slides to analyze, store, and share critical information.  This made it costly and challenging to share tissue samples and other information, critical for timely and effective diagnosis and to discuss treatment options.  BioImagene addressed the need by creating a suite of dynamic, image-based technologies that enable image capture, information management, image analysis and virtual sharing of patients’ tissue samples from glass microscope slides.  Their unique software, iScan, enabled viewing, analysis, and managing of tissue images, using a computer.  Emphasizing the need to adapt and change, Uttarwar said, the pivotal moment in the history of the company was when they made the decision to go into hardware.  They built a unique image viewing input device called the iSlide, and a high performance workstation called Crescendo.  Together their products greatly improved workflow efficiency in image archiving and retrieval, remote viewing, and turnaround time and made them an attractive target and the company was acquired for $100M by Roche, in August, 2010.

Both Uttarwar and Fernandes credited their team and EPPIC for their success.  EPPIC was started with a vision to promote networking, entrepreneurship, and mentoring for life science professionals, by a handful of people of Indian origin and has since vastly expanded.  Uttarwar and Fernandes shared about how they received significant coaching and guidance from prominent EPPIC members and veterans like Nagesh Mhatre, at critical periods.  Additionally, through EPPIC, they connected with Artiman Ventures and received funding as well.  With such a strong community to support and energize, “if I can do it, you can do it”, said Uttarwar.  Mohan Uttarwar is the guest speaker on October, 29 at www.bio2devicegroup.org event, in Sunnyvale, and will be speaking about one of his new ventures.   These are free events and all are welcome.

Please note down following dates (September, 18 and October, 26) for upcoming EPPIC events and register at www.eppicglobal.org.

Enhanced by Zemanta

, , , , , , , , , , , , , , , , , ,

Leave a comment

%d bloggers like this: