Exciting opportunity to join an industry leading organization with a strong product line, fantastic growth opportunities, diverse projects, and a talented team of experts.

Shall play an active role in the design, development, testing, and risk management compliance of in vitro diagnostic medical device products through:

*** Reviewing product designs for potential safety issues.

*** Maintaining DHF (design history file), DMR (device master record), and DHR (device history record) files.

*** Ensuring design compliance to device safety and electromagnetic compatibility requirements.

*** Ensuring adherence to FDA Quality System Regulations (QSRs).

Requires experience with:

*** ISO 14971 - Risk Management for Medical Devices and ISO 13485 - Quality Management Systems (QMS) for Medical Devices

*** EN 61010 - Low Voltage Directive (LVD) and IEC 61326 - Electromagnetic Compatibility (EMC) testing

*** Design Controls and Risk Mitigation for Medical Devices

*** In Vitro Diagnostic (IVD) medical devices

*** FDA Quality System Regulations (QSRs)

*** Design History Files (DHFs), Device Master Records (DMRs), Device History Records (DHRs), Risk Management Files

Fantastic compensation package designed around a top candidate with competitive salary, bonus, long-term incentives (stock ownership, 401(k) with matching contribution, annual reviews, and more!), comprehensive medical plan for whole family with doctor and specialist visits covered, eyeglass and contact prescription costs covered, prescription drug plan, and more!

For details contact Branden F. Lynch at:
(609) 584-9000 ext 241

Or submit resume online at:
http://dmc9.com/bfl/app.asp

Or email to:
1000024563_10007337@jobbank302.com

Please reference #36891314 when responding.

5+ years

California

$100,000.00

$140,000.00

Branden F. Lynch

(609) 584-9000 ext 241

1000024563_10007337@jobbank302.com

http://dmc9.com/bfl/app.asp

WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES: http://najobbank.com www.najobbank.com Top 10 Job Site Top 10 Careers Site Compliance Engineer Specialist Electrical Engineer Quality Engineer BSEE MSEE Electromagnetic Compatibility IEC 61326 ISO 14971 ISO 13485 Medical Device IVD In Vitro Diagnostic LC-MSMS Mass Spectrometry Design Assurance Engineer Risk Management Design Engineer Regulatory Affairs EMC Electromagnetic Compatibility EMI Electromagnetic Interference

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