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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