Sr Process Engineer

 

Senior Process Engineer – Medical Device responsible for leading the clinical build line and driving process development, validation, and commercialization for new products and equipment.

Job Requirements

• 5+ years of medical device industry experience

• BS in Engineering (Mechanical, Chemical, or Biomedical)

• Hands-on process validation experience (e.g., IQ, OQ, PQ)

• Experience supporting new equipment introduction and New Product Development (NPD)

• Experience with electropolishing processes

• Experience using Keyence and Sensofar measurement/inspection technology

• Experience with GR&R and TMV studies

• Experience with IQ documentation and execution

• Experience performing or contributing to FMEAs

Preferred Skills

• Experience leading clinical build or pilot manufacturing lines

• Experience characterizing processes and defining critical process parameters in a regulated environment

• Experience supporting process scale-up from development to full commercialization

• Experience with cleanroom manufacturing environments and medical device quality systems

Job Responsibilities

• Lead clinical build line operations for new and existing medical device products

• Own process development deliverables, including process characterization, optimization, and documentation

• Develop, execute, and maintain process validation documentation (including GR&R, TMV, IQ, and related protocols/reports)

• Characterize critical process parameters and establish process windows for electropolishing and related operations

• Support new equipment introduction, including URS development, IQ activities, and integration into manufacturing

• Collaborate with cross-functional teams to support New Product Development and commercialization activities

• Drive completion of risk analysis activities such as FMEAs for new and existing processes

• Support preparation for regulatory and quality audits related to process validation and manufacturing readiness

Pay: 50-65

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: $50.00 to $65.00 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 California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

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