Design Assurance Engineer Entegee - 3.7 Southborough, MA Job Details Full-time $90,000 - $100,000 a year 3 days ago Benefits Commuter assistance Disability insurance Health insurance Dental insurance 401(k) Paid time off Vision insurance Life insurance Qualifications Developing medical devices Electro-mechanical components Medical device testing Engineering Document control experience within engineering industry Records management Production validation processes Quality risk management Design failure mode and effects analysis (DFMEA) Compliance documentation Design engineering Software testing Design controls Biomedical regulatory compliance Technical writing experience within technology Product design documentation Full Job Description

DESIGN ASSURANCE ENGINEER - MEDICAL DEVICE

Overview Support design controls, risk management, verification and validation, and regulatory compliance activities for Class II electromechanical medical devices. Job Requirements Bachelor's degree in Engineering, Science, or a related technical field 3-5 years of experience supporting engineering and development of Class II electromechanical medical devices Experience with medical device design controls Experience with risk management activities Experience developing or maintaining DFMEA and PFMEA documentation Experience supporting design verification and validation activities Experience with process validation, including IQ, OQ, and PQ Experience supporting software validation Experience maintaining Design History Files and technical documentation 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. #GRP2

Pay:

$90,000.00 - $100,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person