Summary: Seeking a Design Assurance Engineer to ensure compliance and risk minimization in product design within the medical device industry.
Requirements:
Bachelor's Degree in Engineering
Experience in the medical device industry
Preferred Skills:
Knowledge of ISO/EN standards, FDA QSR, EU MDD, and international requirements
Experience with risk analysis documentation and quality plans
Responsibilities:
Support new product development and sustaining teams
Ensure product design meets user requirements and minimizes risk
Evaluate product/process changes and post-market surveillance information
Assist with customer-focused design specifications addressing clinical, engineering, and marketing needs
Develop design verification and validation strategies, including testing activities
Conduct statistical data analysis
Coordinate failure investigations and root cause analysis for product complaints
Pay: 100K-120K
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.
Pay Details: $100,000.00 to $120,000.00 per year
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance
Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.