Mechanical Engineer

Senior Mechanical Engineer – Medical Devices responsible for design verification, test method development, and compliance to IEC standards for Class II/III devices.

Job Requirements:

• Bachelor’s degree in Mechanical Engineering (BSME)

• 4+ years of medical device experience with Class II and/or Class III products

• Experience with design verification and validation activities for medical devices

• Experience with test method development (TMV) and execution

• Proficiency with Gauge R&R studies

• Proficiency using Minitab or similar statistical analysis software

• Experience generating and reviewing design outputs such as drawings, specifications, and test protocols

• Experience creating and maintaining Design History File (DHF) documentation

Preferred Skills:

• Hands-on experience with implantable or active medical devices

• Experience with risk management activities (e.g., FMEA, fault tree analysis)

• Experience with verification traceability (requirements to test methods and results)

• Familiarity with cleanroom or controlled manufacturing environments

Job Responsibilities:

• Plan and execute design verification activities for Class II/III medical devices in compliance with applicable standards

• Develop, validate, and maintain test methods (TMV) for mechanical and system-level tests

• Perform Gauge R&R and statistical analyses using Minitab to support test method robustness and capability

• Ensure designs, test methods, and verification activities comply with IEC 14708, 45502, 60601, and relevant regulatory requirements

• Generate and maintain DHF documentation including protocols, reports, and design outputs

• Define and document design verification strategies, acceptance criteria, and sample size rationales

• Review engineering drawings, specifications, and design outputs to ensure verification coverage and compliance

• Support root cause investigations and design changes through structured verification and re-verification activities

• Contribute technical input to risk management activities and design reviews throughout the product development lifecycle

Pay: 40-51

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: $40.00 to $51.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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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 Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San 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.