Process Engineer

Akkodis is seeking an NPI Process Engineer in Irvine, CA
- Onsite with strong experience in medical device new product introduction (NPI), manufacturing process development, and process validation to support new product development and manufacturing transfer activities. The ideal candidate will have expertise in process development, Design Controls, IQ/OQ/PQ validation, Solid Works, and cross-functional collaboration within a regulated medical device environment.

Pay Range: $40–$43/hr. on W2 (The rate may be negotiable based on experience, education, geographic location, and other factors.)

Responsibilities:

• Lead New Product Introduction (NPI) activities from product development through manufacturing.
• Develop, optimize, and validate manufacturing processes for new medical devices.
• Support Design Transfer from R&D into manufacturing.
• Design and develop electro-mechanical components, fixtures, and manufacturing equipment using Solid Works
  .
• Execute Process Validation (IQ/OQ/PQ) protocols and ensure manufacturing readiness.
• Conduct Design of Experiments (DOE) and analyze engineering data to improve process capability.
• Perform troubleshooting and Root Cause Analysis (RCA) to resolve manufacturing and product issues.
• Collaborate with Manufacturing, Quality, Regulatory, R&D, and Supplier teams throughout the product lifecycle.
• Develop engineering documentation, work instructions, protocols, and technical reports.
• Support supplier qualification, manufacturing process improvements, and continuous improvement initiatives.
• Ensure compliance with FDA regulations, ISO 13485, MDR, GMP, and Design Controls
  .

Required

Skills & Experience:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Mechatronics, or a related engineering discipline.
• Experience in the Medical Device industry
  .
• Strong experience with New Product Introduction (NPI) and New Product Development (NPD).
• Experience developing and improving manufacturing processes.
• Hands‑on experience with Process Validation (IQ/OQ/PQ).
• Experience with Design Verification & Validation (V&V).
• Proficiency with Solid Works or similar CAD software.
• Experience with Design Controls
  , DOE
  , and Root Cause Analysis
  .
• Strong knowledge of FDA regulations, ISO 13485, MDR, and GMP
  .
• Excellent communication, problem‑solving, and cross‑functional collaboration skills.

Preferred Qualifications:

• Experience with electro‑mechanical systems
  , motors, drives, sensors, or PLC programming.
• Experience designing manufacturing fixtures and tooling.
• Lean Manufacturing or Six Sigma experience.
• Experience working with suppliers and contract manufacturers.
• Experience leading small projects or manufacturing process improvements.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short‑term disability, additional voluntary benefits, an 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.

Disclaimer:
These benefit offerings do not apply to client‑recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit .

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