Process Engineer III

 

Manufacturing Engineer for medical devices responsible for Nitinol manufacturing, process validation, and introduction of new products and automated equipment.

Job Requirements

• Bachelor’s degree in engineering or relevant technical field.

• Minimum of 4 years of professional experience in a manufacturing or process engineering role.

• 4+ years of experience in medical device or other regulated industry.

• Experience with Nitinol manufacturing processes.

• Experience with inspection methods and systems in a production environment.

• Experience with automated inspection and/or automated assembly equipment.

• Experience with process verification and validation activities, including TMV, GR&R, IQ, OQ, and PQ.

• Experience supporting New Product Development and/or Operations transfers.

• Experience using FMEAs for risk analysis.

• Demonstrated use of statistics to drive process and product improvements.

• Ability to travel locally up to 10% (no overnight travel).

Preferred Skills

• Experience specifying, qualifying, and commissioning new equipment for medical device manufacturing.

• Experience developing and optimizing inspection strategies for complex components.

• Experience with Nitinol-specific forming, heat treatment, and finishing processes.

• Familiarity with regulatory and quality system requirements for medical devices (e.g., ISO 13485, FDA).

Job Responsibilities

• Support and optimize Nitinol manufacturing processes for existing and new products.

• Lead process verification and validation activities, including development and execution of TMVs and OQ/PQ protocols.

• Develop, implement, and sustain inspection methods, including automated inspection systems.

• Support New Product Development through process definition, equipment selection, and design for manufacturability input.

• Plan and execute IQ activities for new or modified equipment and fixtures.

• Develop and maintain process documentation, work instructions, and validation reports.

• Conduct FMEAs and other risk analyses to identify and mitigate process and product risks.

• Perform root cause investigations for nonconformances and implement effective corrective and preventive actions.

• Analyze process data using statistical methods to monitor performance and identify improvement opportunities.

Pay: 45-55

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: $45.00 to $55.00 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.