Responsible for ensuring product design quality and compliance with regulatory standards in the medical device industry.

Requirements

Bachelor’s degree in Engineering discipline

5–7 years of experience with BS, or 3–5 years with MS

Experience in design assurance, quality, or related regulated industry

Medical device experience preferred

Background in risk management, design quality, and design assurance

Prior experience working in a regulated environment

Preferred Skills

Knowledge of Design History File (DHF) requirements

Familiarity with risk management tools such as Hazard Analysis, Task Analysis, and Design FMEA

Experience with CAPA, PIR, and NCEP processes

Strong documentation and technical writing skills

Responsibilities

Lead and manage design change projects including scoping, assessment, and implementation

Develop, update, and maintain Design History File and design documentation

Create and maintain risk management files including Hazard Analysis, Task Analysis, and Design FMEAs

Develop and execute Design Verification, Validation, and Usability protocols and reports

Support resolution of PIRs, CAPAs, and NCEPs with design quality expertise

Apply structured problem-solving methodologies to identify, prioritize, and resolve quality issues

Pay Details: $40.00 to $52.00 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 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.