Exclusive Sustaining Systems Design Quality Engineer

Requirements

• 3–5 years of experience with a BS (degree must be clearly stated on resume)

• Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering (highly preferred)

• Experience developing and executing Design Verification and Design Validation

• Experience with design control, risk management, and medical device standards compliance

• Experience with corrective and preventive action (CAPA), including NCEP processes

Preferred Skills

• Hands-on hazard analysis and risk control implementation per risk management processes

• DFMEA facilitation and maintenance; familiarity with FMEA/FMECA toolchains

• Complaint analysis and trending tied to CAPA/NCEP

• Basic statistical methods for test planning and data analysis

• Test method validation and protocol/report authorship

• Requirements traceability and change control using lifecycle tools

Responsibilities

• Lead and maintain risk management files, including hazard analyses, risk controls, and DFMEA updates

• Plan, author, and execute DV/DV protocols; compile objective evidence and final reports

• Drive CAPA/NCEP investigations, root-cause analysis, corrections, and effectiveness checks

• Perform complaint data review and trend analysis; escalate and link findings to risk and CAPA

• Ensure compliance to applicable design control and risk management standards throughout the product lifecycle

• Manage requirements traceability, design reviews, and change control documentation across phases

Pay Details: $30.00 to $40.00 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

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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.