B.S. in Biomedical, Mechanical, Electrical Engineering or related field; M.S. preferred Medical-device product development AND design controls/

V&V Must-Haves:

5-7+ years in medical device Quality Assurance, Quality Systems, or Product Engineering Strong Design Controls experience Design Verification & Validation (V&V) and product validation Experience taking products through design, prototyping, testing, validation, and lifecycle support ISO 13485 and

FDA 21 CFR

Part 820 PLM / product lifecycle management Design analysis, technical documentation, and engineering specifications Risk management, FMEA, design reviews, and change control Cross-functional work with

R&D, Quality, Regulatory, and Manufacturing Specialized Requirements:

Experience implementing or improving an

ISO 13485 QMS

Knowledge of Singapore medical device regulatory requirements Experience supporting/leading

GDPMDS/GDP

certification Experience working with certification/accreditation bodies and regulatory authorities #GRPB Equal Opportunity Employer/Veterans/Disabled. Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records .

Pay:

$50.00 - $55.00 per hour Expected hours: No less than 40.0 per week

Benefits:

401(k) Dental insurance Health insurance Vision insurance People with a criminal record are encouraged to apply

Work Location:

In person