Archive for category JOB OPENINGS

JOBS – June, 2017



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All US based opportunities require valid US work visa and prior experience in biomedical industry.  If interested in any opportunities below, please send me an email (resume as an attachment) and include position title in the subject line.  You can also find me on LinkedIn. (Or send me a message with title of the position that interests you, how it matches your background & your contact info). 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. Emails with proper subject line, some details in the body of the email to my hot mail address or linkedin will get quicker response.  Besides below opportunities, more opportunities are coming in Quality Engineering and Regulatory.

Test/ Quality Engineer – Santa Cruz, CA
There is an exciting opportunity for Test/Quality Engineer for a company located in Santa Cruz – CA, with an array of brain computer interface devices to address a range of neurological problems.  Candidate is required to have 2 to 5 years of medical quality system experience as well as sw/hw test experience in electromechanical systems. 

Mechanical Engineer – Santa Cruz, CA
There is an exciting opportunity for Mechanical Engineer for a company located in Santa Cruz – CA, with an array of brain computer interface devices to address a range of neurological problems.  Candidate is required to have 2 to 5 years of medical device experience in electromechanical systems.

Digital Marketing Manager – Sunnyvale, CA
Exciting cancer genomics company has an opening for someone to head digital marketing.  Hands-on social media marketing experience and knowledge of platforms to generate and drive traffic is required.

Director of Engineering – Hong Kong

There is an exciting opportunity for Director of Engineering for a robotic surgery company located in Hong Kong.  This is an opportunity to work with a great  team on cutting edge technology with a potential to alter healthcare in a meaningful way.  Significant stock options in addition to relocation package and salary commensurate with experience, makes it a very exciting opportunity for long or short stint in Hong Kong.

Responsibilities
Compile & conduct presentations on company’s products; Conduct technical reviews of products; Work with teams in marketing, product compliance and registration; Compile & conduct technical presentations, technological analysis reports; Identify technological trends; and Provide technical advice.

Requirements
5+ years hands-on product development experience in an ODM setting, preferably on products requiring integration of cross-discipline technologies, among high-precision multi-DoF mechanical drivetrains, real-time embedded control software, video systems and optic; and ability to build external strategic alliances & partnerships. Also required fluency in English. Highly preferred academic degree in two different engineering disciplines and MBA is an additional advantage.

Embedded Software Engineer – Austin, TX

There is an immediate opportunity for Embedded Software Engineer for a company working on technology with a potential to alter future of care.

Responsibilities: Design & develop software for very low power, battery operated implantable & other medical devices consisting of a mixture of analog, digital and RF circuitry in highly integrated, low power embedded systems; design & develop externals and wereables for implantable & other medical devices; Document software design & implementation including requirement specs; Support V&V testing; Ensure compliance with FDA, ISO, AAMI & UL standards.

Requirements: BS in Electrical, Computer or Software Engineering; 15+ years experience in design & development of embedded systems including for medical devices; Strong expertise in embedded C/C++ programming including optimization for performance & memory usage; Experience developing applications which run a variety of OS/ RTOS targets; Experience in structural development environment with source control & bug tracking systems; Experience developing low level device drivers for hardware peripheral interfaces & devices like SPI, 12C, USB, LCD, ADC, DAC, RFIC; Experience with a variety of CPU architecture (Arm Cortex M3/M4 TI MSP430 etc. Must have experience with board bring up, effective use of hardware test equipment including logic analyzers, digital storage oscilloscopes etc. LabVIEW & related execution and test setup experience preferred.

For this opportunity, design experience with bare metal embedded systems under an FDA-compliant QMS is absolutely essential.

Senior Electrical Hardware Engineer – Austin, TX

There is an immediate opportunity for Electrical Hardware Engineer for a company led by veteran leaders, disruptive technology, and highly experienced team. This position will report to VP of product development.

Responsibilities: R&D design & development of implantable and associated wearable & external hardware using mixed signal, analog & digital techniques, sensors & actuators, and closed loop control systems; Develop wireless charging & wireless communications; Manufacturing including process development, qualification & validation, part/ component selection; Develop power efficient, reliable & hermetically sealed & packaged Class II/III implantable electronics to be compliant with regulatory & QA standards (FDA & ISO); Work in a matrixed & multi disciplinary organizational structure.

Requirements: BS in EE; 10+ years experience in design, development & implementation of electronics & mixed-signal hardware, firmware & software for implantable medical devices; Hands-on leadership in with electronics hardware and software, analog, digital, sensors, actuators, power management and wireless communications; Experience with qualified sensors for both implantable device function and for measuring physiological parameters; Experience with implantable device components like connectors, leads, cables, interconnectors, headers, electronics packaging, communication protocols & standards. Microwave programming a plus. Experience with EDA tools: sensors/ circuit design, simulation, layout, circuit and system prototyping & development; Experience implementing manufacturability & related process flows & controls; vendor selection for manufacturability of medical devices; Working knowledge of biocomaterials, drugs, drug delivery & mechanical technologies in support of multidisciplinary teams.

VP OF MARKETING – Sunnyvale, CA

A global company with a breakthrough solution in the fight against cancer has an immediate opening for VP, Marketing.  The company seeks to dramatically transform early cancer detection through simple & accurate blood tests.

Responsibilities: Develop & implement product & brand strategies; Drive commercial results; Work cross-functionally; Develop strategies/initiatives worldwide to drive growth; Lead creation and design of new product portfolio; Develop comprehensive marketing strategy for products across multiple channels, including direct to consumer and product segments; Develop, execute & manage cohesive geographic expansion plan taking into account market potential, clinical and regulatory pathways, exclusivity, and strategic alignment; Develop marketing strategy to ensure sales goals; Expand relations with KOLs & customers; Hire and lead Marketing team; Maintain industry awareness.

Requirements: Experience in launch & commercialization of innovative, first-in-class lab developed tests; Strong collaborator; Contribute to creation of a brand plan that enforces a highly collaborative and effective commercial organization. Qualifications required: BA plus 10+ years experience in diagnostic industry in conception, development & execution of marketing strategies for highly specialized products in China, Taiwan, India & S E Asia and US. Experience in building corporate brand from grounds up, in developing compelling data-driven pitch decks for various strategic recommendations, in presentations, in marketing to diverse customer segments, in mentoring, in “out of box” innovative thinking & strong customer orientation. MBA and fluency in English & Mandarin preferred.

Head of Asceptic Manufacturing – San Jose, CA

There is an immediate opening to head Asceptic Manufacturing for Drug Device company in San Jose, CA.  Requires strong engineering background and expertise in setting up asceptic manufacturing.  Opportunity for profit sharing in exciting technology company along with an opportunity to work with a top notch team and a veteran leader are great pluses.

PRODUCT MANAGER, GENOMICS – Sunnyvale, CA

A global company with a breakthrough solution in the fight against cancer through novel and dramatically transforming early cancer detection through simple and accurate blood tests has an immediate opening for Product Manager. This breakthrough technology is already creating patient impact in Asia. Reporting to the VP of Marketing, the Product Manager will be a driver for key products and will be responsible for the product strategy as well as the design of all genomic products. Working closely with sales and cross functional leadership in R&D, clinical and medical functions, the candidate will develop initiatives worldwide to drive revenue growth.

Responsibilities: Define product strategy & roadmap and deliver product requirements with prioritized features; Develop the core positioning & messaging; work cross functionally to drive technical & clinical development of the product; understand competition & incentives for all stakeholders in the system to drive growth of the product; Create marketing communications materials for physicians; Brief & train sales force on product benefits & features; Work closely with marketing team in Asia to design & implement local programs to support product goals; Support marketing team in organizing special event & marketing campaigns; Manage company presence at conferences & tradeshows; Manage media, PR, digital marketing & social media campaigns  About 30% travel required.
Requirements: Background in molecular & cell biology, experience in healthcare product marketing or product management. Fluency in Mandarin desirable.

DIRECTOR OF R&D – San Jose, CA

There is an exciting opportunity for Manager/ Director of R&D with hands on mechanical engineering & polymer chemistry expertise.  The company is located in Northern San Jose, CA. This is a once in a lifetime kind of an opportunity to be included in profit sharing and work on disruptive technology with an exciting team and a veteran leader.

PHARMACOLOGIST with Large Animal In-Vivo Survival Surgery Experience
San Jose, CA

Innovative life science company with several life saving technologies has an immediate opportunity for a pharmacologist for animal studies. DVM ok.

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JOBS: May, 2017


Image result for jobsAll US based opportunities require valid US work visa and prior experience in biomedical industry.  If interested in any opportunities below, please send me an email (resume as an attachment) and include position title in the subject line.  You can also find me on LinkedIn. (Or send me a message with title of the position that interests you, how it matches your background & your contact info). 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. Emails with proper subject line, some details in the body of the email to my hot mail address or linkedin will get quicker response.

Embedded Software Engineer – Austin, TX

There is an immediate opportunity for Embedded Software Engineer for a company working on technology with a potential to alter future of care. 

Responsibilities: Design & develop software for very low power, battery operated implantable & other medical devices consisting of a mixture of analog, digital and RF circuitry in highly integrated, low power embedded systems; design & develop externals and wereables for implantable & other medical devices; Document software design & implementation including requirement specs; Support V&V testing; Ensure compliance with FDA, ISO, AAMI & UL standards.

Requirements: BS in Electrical, Computer or Software Engineering; 15+ years experience in design & development of embedded systems including for medical devices; Strong expertise in embedded C/C++ programming including optimization for performance & memory usage; Experience developing applications which run a variety of OS/ RTOS targets; Experience in structural development environment with source control & bug tracking systems; Experience developing low level device drivers for hardware peripheral interfaces & devices like SPI, 12C, USB, LCD, ADC, DAC, RFIC; Experience with a variety of CPU architecture (Arm Cortex M3/M4 TI MSP430 etc. Must have experience with board bring up, effective use of hardware test equipment including logic analyzers, digital storage oscilloscopes etc. LabVIEW & related execution and test setup experience preferred.

Senior Electrical Hardware Engineer – Austin, TX

 

There is an immediate opportunity for Electrical Hardware Engineer for a company led by veteran leaders, disruptive technology, and highly experienced team. This position will report to VP of product development.  

Responsibilities: R&D design & development of implantable and associated wearable & external hardware using mixed signal, analog & digital techniques, sensors & actuators, and closed loop control systems; Develop wireless charging & wireless communications; Manufacturing including process development, qualification & validation, part/ component selection; Develop power efficient, reliable & hermetically sealed & packaged Class II/III implantable electronics to be compliant with regulatory & QA standards (FDA & ISO); Work in a matrixed & multi disciplinary organizational structure.

Requirements: BS in EE; 10+ years experience in design, development & implementation of electronics & mixed-signal hardware, firmware & software for implantable medical devices; Hands-on leadership in with electronics hardware and software, analog, digital, sensors, actuators, power management and wireless communications; Experience with qualified sensors for both implantable device function and for measuring physiological parameters; Experience with implantable device components like connectors, leads, cables, interconnectors, headers, electronics packaging, communication protocols & standards. Microwave programming a plus. Experience with EDA tools: sensors/ circuit design, simulation, layout, circuit and system prototyping & development; Experience implementing manufacturability & related process flows & controls; vendor selection for manufacturability of medical devices; Working knowledge of biocomaterials, drugs, drug delivery & mechanical technologies in support of multidisciplinary teams.  

VP OF MARKETING – Sunnyvale, CA

A global company with a breakthrough solution in the fight against cancer has an immediate opening for VP, Marketing.  The company seeks to dramatically transform early cancer detection through simple & accurate blood tests.

Responsibilities: Develop & implement product & brand strategies; Drive commercial results; Work cross-functionally; Develop strategies/initiatives worldwide to drive growth; Lead creation and design of new product portfolio; Develop comprehensive marketing strategy for products across multiple channels, including direct to consumer and product segments; Develop, execute & manage cohesive geographic expansion plan taking into account market potential, clinical and regulatory pathways, exclusivity, and strategic alignment; Develop marketing strategy to ensure sales goals; Expand relations with KOLs & customers; Hire and lead Marketing team; Maintain industry awareness.

Requirements: Experience in launch & commercialization of innovative, first-in-class lab developed tests; Strong collaborator; Contribute to creation of a brand plan that enforces a highly collaborative and effective commercial organization. Qualifications required: BA plus 10+ years experience in diagnostic industry in conception, development & execution of marketing strategies for highly specialized products in China, Taiwan, India & S E Asia and US. Experience in building corporate brand from grounds up, in developing compelling data-driven pitch decks for various strategic recommendations, in presentations, in marketing to diverse customer segments, in mentoring, in “out of box” innovative thinking & strong customer orientation. MBA and fluency in English & Mandarin preferred.

Head of Asceptic Manufacturing – San Jose, CA

There is an immediate opening to head Asceptic Manufacturing for Drug Device company in San Jose, CA.  Requires strong engineering background and expertise in setting up asceptic manufacturing.  Opportunity for profit sharing in exciting technology company along with an opportunity to work with a top notch team and a veteran leader are great pluses.

PRODUCT MANAGER, GENOMICS – Sunnyvale, CA

A global company with a breakthrough solution in the fight against cancer through novel and dramatically transforming early cancer detection through simple and accurate blood tests has an immediate opening for Product Manager. This breakthrough technology is already creating patient impact in Asia. Reporting to the VP of Marketing, the Product Manager will be a driver for key products and will be responsible for the product strategy as well as the design of all genomic products. Working closely with sales and cross functional leadership in R&D, clinical and medical functions, the candidate will develop initiatives worldwide to drive revenue growth.

Responsibilities: Define product strategy & roadmap and deliver product requirements with prioritized features; Develop the core positioning & messaging; work cross functionally to drive technical & clinical development of the product; understand competition & incentives for all stakeholders in the system to drive growth of the product; Create marketing communications materials for physicians; Brief & train sales force on product benefits & features; Work closely with marketing team in Asia to design & implement local programs to support product goals; Support marketing team in organizing special event & marketing campaigns; Manage company presence at conferences & tradeshows; Manage media, PR, digital marketing & social media campaigns  About 30% travel required.
Requirements: Background in molecular & cell biology, experience in healthcare product marketing or product management. Fluency in Mandarin desirable.

DIRECTOR OF R&D – San Jose, CA

There is an exciting opportunity for Manager/ Director of R&D with hands on mechanical engineering & polymer chemistry expertise.  The company is located in Northern San Jose, CA. This is a once in a lifetime kind of an opportunity to be included in profit sharing and work on disruptive technology with an exciting team and a veteran leader.

PHARMACOLOGIST with Large Animal In-Vivo Survival Surgery Experience
San Jose, CA

Innovative life science company with several life saving technologies has an immediate opportunity for a pharmacologist for animal studies. DVM ok.

 

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JOBS – April, 2017


Image result for jobsAll US based opportunities require valid US work visa and prior experience in biomedical industry.  If interested in any opportunities below, please send me an email (resume as an attachment) and include position title in the subject line.  You can also find me on LinkedIn. (Or send me a message with title of the position that interests you, how it matches your background & your contact info). 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.

VP OF MARKETING – Sunnyvale, CA
A global company with a breakthrough solution in the fight against cancer has an immediate opening for VP, Marketing.  The company seeks to dramatically transform early cancer detection through simple & accurate blood tests.

Responsibilities: Develop & implement product & brand strategies; Drive commercial results; Work cross-functionally; Develop strategies/initiatives worldwide to drive growth; Lead creation and design of new product portfolio; Develop comprehensive marketing strategy for products across multiple channels, including direct to consumer and product segments; Develop, execute & manage cohesive geographic expansion plan taking into account market potential, clinical and regulatory pathways, exclusivity, and strategic alignment; Develop marketing strategy to ensure sales goals; Expand relations with KOLs & customers; Hire and lead Marketing team; Maintain industry awareness.

Requirements: Experience in launch & commercialization of innovative, first-in-class lab developed tests; Strong collaborator; Contribute to creation of a brand plan that enforces a highly collaborative and effective commercial organization. Qualifications required: BA plus 10+ years experience in diagnostic industry in conception, development & execution of marketing strategies for highly specialized products in China, Taiwan, India & S E Asia and US. Experience in building corporate brand from grounds up, in developing compelling data-driven pitch decks for various strategic recommendations, in presentations, in marketing to diverse customer segments, in mentoring, in “out of box” innovative thinking & strong customer orientation. MBA and fluency in English & Mandarin preferred.

Head of Asceptic Manufacturing – San Jose, CA
There is an immediate opening to head Asceptic Manufacturing for Drug Device company in San Jose, CA.  Requires strong engineering background and expertise in setting up asceptic manufacturing.  Opportunity for profit sharing in exciting technology company along with an opportunity to work with a top notch team and a veteran leader are great pluses.

PRODUCT MANAGER, GENOMICS – Sunnyvale, CA
A global company with a breakthrough solution in the fight against cancer through novel and dramatically transforming early cancer detection through simple and accurate blood tests has an immediate opening for Product Manager. This breakthrough technology is already creating patient impact in Asia. Reporting to the VP of Marketing, the Product Manager will be a driver for key products and will be responsible for the product strategy as well as the design of all genomic products. Working closely with sales and cross functional leadership in R&D, clinical and medical functions, the candidate will develop initiatives worldwide to drive revenue growth.

Responsibilities: Define product strategy & roadmap and deliver product requirements with prioritized features; Develop the core positioning & messaging; work cross functionally to drive technical & clinical development of the product; understand competition & incentives for all stakeholders in the system to drive growth of the product; Create marketing communications materials for physicians; Brief & train sales force on product benefits & features; Work closely with marketing team in Asia to design & implement local programs to support product goals; Support marketing team in organizing special event & marketing campaigns; Manage company presence at conferences & tradeshows; Manage media, PR, digital marketing & social media campaigns  About 30% travel required.
Requirements: Background in molecular & cell biology, experience in healthcare product marketing or product management. Fluency in Mandarin desirable.

DIRECTOR OF R&D – San Jose, CA
There is an exciting opportunity for Manager/ Director of R&D with hands on mechanical engineering & polymer chemistry expertise.  The company is located in Northern San Jose, CA. This is a once in a lifetime kind of an opportunity to be included in profit sharing and work on disruptive technology with an exciting team and a veteran leader.  

PHARMACOLOGIST with Large Animal In-Vivo Survival Surgery Experience
San Jose, CA

Innovative life science company with several life saving technologies has an immediate opportunity for a pharmacologist for animal studies. DVM ok.

 

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JOBS – January, 2017


img_20160913_221405.jpgAll US based opportunities require valid US work visa and prior experience in biomedical industry.  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.  If you identify the position that correctly fits your experience & geographic preference and include in the email details on how it matches your background, your current comp and comp expectations, then it will get my first attention.  All leads or referrals are greatly appreciated.  More details on all opportunities below will be posted soon.

Director of Clinical Studies: Stealth Mode CHD Startup – Palo Alto, CA
There is a very exciting opportunity in a stealth mode startup being advised by a veteran entrepreneur with huge prior success.  Right candidate is someone who knows how to develop protocols, organize operational and quality conformance aspects, conduct the study, close it out all the way to final report, has regulatory interaction experience, and all of this in the arena of medical devices for coronary and peripheral vascular interventions.
This could be an associate/director of clinical development level position.More details will be posted soon).

Head of Asceptic Manufacturing for Drug Device Company – San Jose, CA

Chief Commercialization Officer (with background in Immunotherapy & BioInformatics) – Mountain View, CA

Senior Mechanical Engineer w/ background in Polymers & Catheter Engineering  – San Jose, CA

Senior Electrical Engineer w. Implantable Electronics Analog Design Medical Device Experience – San Jose, CA

Cardiovascular Clinical Studies Design Engineer – Redwood City, CA

Senior Electrical Engineer w. Implantable Medical Device Electronics, Digital Design Experience – San Jose, CA

Senior Engineer w Injection Molding Experience – San Jose, CA

Senior Technician w Medical Device Implantable work experience  – San Jose, CA

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JOBS – September, 2016


img_20160913_100250028.jpgAll US based opportunities require valid US work visa and prior experience in biomedical industry.  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.  If you identify the position that correctly fits your experience & geographic preference and include in the email details on how it matches your background, your current comp and comp expectations, then it will get my first attention.  All leads or referrals are greatly appreciated.

Director of Mechanical Engineering – San Jose, CA

There is an opening for Director of Mechanical Engineering, for a medical device company, located in San Jose, CA.  The position requires 12+ years experience in Class II and III medical devices and substantial  background and depth in polymer science, in addition to a solid hands-on engineering background in mechanical engineering.

Reliability Engineer – Milpitas, CA

There is an opportunity for reliability engineer with 8+ years of experience in aerospace, military or related industries.  Ideally a background with some combination in polymer science, material science and mechanical engineering preferred.  This will offer an opportunity to work on something truly exciting and life changing, with a great team.  Stock options will be a huge upside in this opportunity.

Physiologist/ Pharmacologist with In-Vivo Experience: San Jose, CA

A dynamic company, founded by a veteran leader, involved in the development of drug-device combination products for treating chronic diseases, has an opening for a Biologist. This is once in a lifetime kind of an opportunity to work on exciting technology with game changing potential. The candidate must have hands-on research experience including in vivo experience esp with large animal models during their doctoral and post-doctoral training period. The ideal candidate will have a Ph.D. in Physiology/Pharmacology or any other related Biology discipline or a DVM with research experience. The individual is expected to have a breadth of experience in both in vitro and in vivo biological research supporting various drug/ device development programs across multiple therapeutic areas including CNS, oncology, cardiovascular and metabolic diseases.  The individual will support and work with external institutions including CROs and academic institutions especially for conducting in vivo studies in small as well as large animals. Additionally the individual will set up and run a variety of routine in vitro research paradigms in house as needed such as isolated tissue and cell-based assays as well as quantitative assays for small molecules, peptides and proteins using techniques such as FTIR, HPLC, and immunoassay. The individual will work with a multidisciplinary team of experts and provide biology support with minimal supervision on various ongoing projects.

DVM working for either a mid-sized CRO or industry could be a good fit.

Technician – San Jose, CA

This position supports the development, commercialization, market release, and post release support of a family of products that perform water quality measurement and treatment for pools and spas. The scope of work includes laboratory and testing, prototype fabrication, manufacturing process and equipment development, and field testing of product. This funded, early stage start-up has a mission to create a family of novel IOT products to fill an un‐served market.

Duties include:

  • Conduct test and collect data both in‐house and in the field
  • Assemble prototype products
  • Fabricate and/or modify components for testing
  • Inspect incoming mechanical and electronic components and raw materials  
  • Handle hazardous chemicals
  • Manage inventories of raw materials, components, and chemicals
  • Clean and organize workplace
  • Maintain a safe workplace for self and others
  • Troubleshoot and perform analysis of failed hardware
  • Build and set‐up production and test equipment
  • Calibrate and maintain equipment  
  • Assist engineers and scientists as needed

Hard skills:

  • Math skills (High School level minimum)
  • Computer skills (e‐mail, Word, and Excel, CAD experience a plus, Linux experience a plus)
  • Operate electronic and mechanical measurement instruments  
  • Comfort with IOT products communicaĕng to smart phones
  • Soldering electronic components
  • Plumbing
  • Capable of lifting 30 pounds unassisted
  • Operate machine shop equipment
  • Perform laboratory measurements including interpreting color strips (cannot be color blind)

Soft skills:

  • Fluent in English  
  • Good attitude  
  • Meticulous record keeping
  • Keeps workplace clean and organized
  • Safety oriented (understands industrial safety)
  • Enjoys being creaĕve
  • Takes direction readily
  • Able to direct self when other direction is not provided
  • Valid driver’s license
  • Interested in and enjoys early‐phase start‐up experience
  • Wants to learn and grow professionally as the company grows

Experience:

  • 5‐15 years with a variety of experience as a calibration technician, maintenance mechanic, electronics technician, or R&D technician
  • Consumer product experience
  • Familiarity with pool care is a plus

Analog Engineer – San Jose, CA

This opportunity requires 8+ years of analog design experience, preferably for class 2 and class 3 medical devices.  It is a senior level opportunity ideal for a candidate who has passion for hands on engineering and is good in managing a team.

Firmware Engineer – San Jose, CA

This opportunity requires 8+ years of firmware/ embedded systems experience for class 2 and class 3 medical devices.  It is a senior level opportunity ideal for a candidate who has passion for hands on engineering and is good in managing a team.

Patent Attorney – San Jose, CA

In-house opportunity in medical device company with disruptive technologies to solve pressing health problems, requires 15+ years of medical device patent prosecution experience.

Patent Paralegal – San Jose, CA

The position will be assisting in-house counsel working on USPTO and foreign filings, office actions, assignments and other related USPTO filings for a variety of medical device and pharmaceutical related patent applications. They will be proofing and editing patent applications and office actions and prepping office actions. They will be developing and tracking dockets (US and foreign), filing on line assignments, working with the deposit accounts and reviewing IP related documents and agreements.

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

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JOBS – July, 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, Business Development 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.  If you identify the position that correctly fits your experience & geographic preference and include in the email details on how it matches your background, your current comp and comp expectations, then it will get my first attention.  All leads or referrals are greatly appreciated.

Patent Paralegal – San Jose, CA

The position will be assisting in-house counsel working on USPTO and foreign filings, office actions, assignments and other related USPTO filings for a variety of medical device and pharmaceutical related patent applications. They will be proofing and editing patent applications and office actions and prepping office actions. They will be developing and tracking dockets (US and foreign), filing on line assignments, working with the deposit accounts and reviewing IP related documents and agreements.

Requirements:

  • Four year college degree. Paralegal certificate preferred but not required
  • 5 years of paralegal experience mainly with the U.S. patent prosecution and some foreign prosecution and trademark work
  • Excellent computer and typing skills (including proficiency on Word and Excel), proof and editing skills
  • Comprehensive knowledge of USPTO patent procedures and patent claim format
  • Experience with docketing tracking software and patent licenses are a plus
  • Technical background and prior experience with medical device and drug related patents is preferred

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 – 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 – May, 2016


Most of my current needs are in engineering.  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.  I will be happy to share a gift (if reminded, after a successful outcome), for any leads or referrals.

Details on the opportunities below will be posted soon.  Feel free to send in resumes.  All opportunities require medical device experience.  Drug delivery background, a plus.  All opportunities below require 7+ years experience and requires US valid work visa.
Director of Engineering – San Jose, CA
(Medical device implantable experience and hands-on engineering passion required).
Automatic Test Equipment Engineer – San Jose, CA
Quality Engineer – San Jose, CA

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

Biochemist – San Jose, CA

Leads Engineer – Austin, TX

Innovative, well funded bio-medical startup with disruptive technology has an exciting opportunity for Leads Engineer opportunity, near Austin, TX.  This offers an opportunity for stock options upside in a promising startup, in addition to working on something truly exciting. 

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

Innovative, well funded bio-medical startup with disruptive technology has an exciting opportunity for embedded software/ firmware engineer opportunity, near Austin, TX.  Offers an opportunity to work on life changing and exciting product with stock options upside.  

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

  • Responsibilities:
    Develop firmware for very low-power, battery powered systems consisting of a mixture of analog, digital and RF circuitry in highly integrated, low power embedded designs
  • Key member of a cross-functional team. Participate in design activities at both the architectural and implementation levels.
  • Design and implementation of error checking and fault handling, robustness and safety features
  • Document software design and implementation, including requirement specifications
  • Support verification and validation testing, work closely with the verification and validation team to develop test plans and protocols
  • Adhere to standards to help ensure compliance with Food and Drug Administration (FDA), International Organization for Standardization (ISO), Association for the Advancement of Medical Instrumentation (AAMI), and Underwriter’s Laboratories (UL) standards. 

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 & document test protocols in component & system reliability, failure analysis.
* Ensure compliance with regulations including QSR, ISO Standards & corporate policies.
* Specify and purchase components for test setups and prototypes.
* Procure & maintain engineering lab equipment in accordance with quality practices.


Analog Design Engineer – San Jose, CA

Innovative, well funded bio-medical startup with disruptive technology has an exciting opportunity for analog design and embedded systems engineer, 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.  


Senior Electrical Engineer – Mt. Laurel, NJ

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 include: B.S. in Electrical Engineering; 5+ years experience as R&D electrical engineer in regulated industries (i.e Medical, defense, etc.); Applications development & Project Management experience; experience writing protocols, reports, regulatory documents; Understating of patent applications & processes.  Experience in circuit design (Analog and mixed-mode circuits) and with digital signal processing algorithms, a big plus.

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


Embedded Systems Engineer – San Jose, CA

Innovative, well funded bio-medical startup with disruptive technology has an exciting opportunity for analog design and embedded systems engineer, 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.  


Director – Quality Assurance – Mt. Laurel, NJ

An innovative medical device company focusing on cardiac health has immediate opening for Director, Quality Assurance for its offices in Mount Laurel, New Jersey.  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 training of employees 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 and regulatory compliance at US clinical trial investigational sites. This responsibility is carried out by conducting on-site monitoring visits with the Investigator and other key research personnel during the course of the sponsored trials.

Primary Responsibilities
* Orient site personnel to study protocol/procedures
* Monitor compliance to FDA Regulations and study protocol
* Monitor and promote compliance to local IRB reporting regulations
* Manage study site activities through frequent on-site visits
* Perform initial, interim and closeout study visits
* Communicate findings to investigators and 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 and written reports to the Clinical Affairs department after each monitoring visit

Additional Responsibilities
* Schedule on-site monitoring activities and travel in conjunction with the Clinical Affairs department & 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.
* Experienced in cardiac medical device related clinical trials
* Experienced 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 all necessary documentation.

 

 

 

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JOBS – April, 2016


For the opportunities below, please send resume ASAP and include in the subject line the title of the job you are interested in.  Include in the email some info on why you think it might be a good match with your background.  Please send resume to wd_darshana at hot mail.  Feel free to connect with me on LinkedIn, if you work in life sciences or high tech arena.  My most imminent opportunity is for analog design engineer.  See below.

Electrical Engineer:  San Jose, CA

Innovative bio-medical company with disruptive technology has an exciting opportunity for principal electrical engineer with analog design and embedded systems experience, 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.  Job duties described below are pertaining to some imminent needs but specific work responsibilities will change and there will be opportunities to work on several exciting projects.

Job Duties/Responsibilities: The position is responsible for the design and development of an external inductively coupled charging system for a rechargeable implanted medical device. The position will work closely with a firmware engineer responsible for developing communications and implementing the charging algorithms. The position will also be expected to provide general electrical engineering support to a team of firmware, software, and mechanical engineers responsible for other system components as needed.
* Design and development of inductive charging coil (s) for transcutaneous charging of an implanted medical device. Position is responsible for developing the optimal coil design/dimensions, design of any hardware required for localization/alignment of coils, management of thermal properties and heating of devices and tissue.
* Adaption of existing power electronics to supply the inductive coil.
* Adaption of existing digital electronics used to control charging sequences, device communications and interface with the user
* Design verification testing, including agency testing for conformance with 14708-1, 14708-3 and the applicable 60601-1 series.
* Follow FDA compliant procedures and deliver FDA quality documentation of all design and verification testing
* Working effectively with firmware, software, and mechanical engineers on the project as well as working effectively with off-site partner for technology transfer and development of consensus on shared responsibilities.
* Work effectively with lab technicians and manufacturing engineering/automated test engineering.

Job Qualifications:
* Education: BS Electrical Engineering with a focus in analog and/or electromagnetics, MS preferred.
* Experience: 7-10 years of experience in relevant electrical engineering tasks. Experience with inductive or RF powering/communications (eg RFID tags, wireless charging for consumer applications (eg cellphone), MRI R&D/testing) is required, inductive low frequency magnetically coupled charging is preferred. Experience in computer simulation of magnetic fields is desirable.
* Skills: Hands on electrical design of charging coils. Hands on electrical design of power circuitry. Hands on experience with rechargeable batteries, recharging characteristics, and heating. Good working knowledge of CAD tools for electrical circuit design and board layout/fabrication. Good electrical lab and troubleshooting skills. Familiarity with digital design and interfacing. Ability to work independently and in small teams.

Director of Quality – San Jose, CA

An Exciting drug delivery company has an immediate opening for Director of Quality.  This position requires a rich quality background and strong experience in either class III devices or pharma.  Requires experience of implementing quality systems and with running a strong quality organization with several direct reports.

Engineering Program Management Leader – San Jose, CA

Innovative startup with complex array of projects, with disruptive technology, has an exciting opportunity for program and project management leader.  This individual will drive the program/ project teams to scope and schedule baselines; will remain focused on delivering to all committed milestones and hold project teams accountable; and will communicate regularly to peers and management to set expectations and remain in alignment on deliverables.  Strong background and deep understanding of engineering, technology, tooling, and manufacturing is absolutely required.

Senior Mechanical Engineer – Milpitas, CA

Novel technology company focused on delivering cost-effective solutions for improving detection and prevention of cancer has an immediate opening for Senior Mechanical Engineer.  Requires MATLAB, LabVIEW skills.

 

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JOBS – March, 2016


For the opportunities below, please send resume ASAP and include in the subject line the title of the job you are interested in.  Include in the email some info on why you think it might be a good match with your background.  Please send resume to wd_darshana at hot mail.  Feel free to connect with me on LinkedIn, if you work in life sciences or high tech arena.  Some of the opportunities below are same as last month but description has changed.

Engineering Program Management Leader – San Jose, CA

Innovative startup with complex array of projects, with disruptive technology, has an exciting opportunity for program and project management leader.  This individual will drive the program/ project teams to scope and schedule baselines; will remain focused on delivering to all committed milestones and hold project teams accountable; and will communicate regularly to peers and management to set expectations and remain in alignment on deliverables.  Strong background and deep understanding of engineering, technology, tooling, and manufacturing is absolutely required.

Senior Mechanical Engineer – Milpitas, CA

Novel technology company focused on delivering cost-effective solutions for improving detection and prevention of cancer has an immediate opening for Senior Mechanical Engineer.  Requires MATLAB, LabVIEW skills.  More details will be posted soon.

Director of Manufacturing – San Jose, CA

Innovative medical device company has a very exciting opportunity for Director of Manufacturing Engineering.  This position will be responsible for leading the team from R&D to manufacturing with a relentless focus on equipment and processes to drive maximum efficiency, maximize reliability and minimize cost.  This position is ideal for someone with a mechanical engineering background and someone who likes to build machines and is a tinkerer.  Additional background in pharma would be a huge plus.

Director of Quality – San Jose, CA

An Exciting drug delivery company has an immediate opening for Director of Quality.  This position requires a rich quality background and strong experience in either class III devices or pharma.  Requires experience of implementing quality systems and with running a strong quality organization with several direct reports.

Analog Design & Embedded Systems Engineer – San Jose, CA

Innovative, well funded bio-medical startup with disruptive technology has an exciting opportunity for analog design and embedded systems engineer, 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.  

Lab Manager – Mountain View, CA

A startup with unique biopsy platform technology for detection of cancer, using both cell based and genomic technologies, has an immediate opening for Lab Manager, in Mountain View, CA.  This can be a part-time or full-time opportunity for the right candidate.

Minimum Qualifications:
The lab manager must possess an active, valid license issued by the State of California 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) and
(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 Management Leader – San Jose, CA – Likely to be soon FILLED

Innovative  drug-delivery company has an exciting opportunity for project management leader with pharmaceutical development background.  This individual will drive the team to meet deliverables on time and within budget, and will communicate regularly with peers and management to set expectations and remain in alignment on deliverables.  Strong understanding of analytical chemistry, molecular biology, and in vivo pharmacology is absolutely required.

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