Product Development Engineer

Job Title : Product Development Engineer

Location : Irvine, CA

Job Type : Long-Term Contract

Job Description :

We are seeking a Product Development Engineer to support New Product Development (NPD) activities for medical devices. The engineer will contribute to the design, development, and verification of innovative medical device products, working closely with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing.

Responsibilities :

Responsible for new product development projects from concept through commercialization.

Develop design inputs, specifications, and risk management documentation in alignment with ISO 13485, FDA 21 CFR 820, and ISO 14971 requirements.

Collaborate with cross-functional teams to ensure product design meets usability, biocompatibility, and sterility requirements.

Design and execute verification and validation (V&V) protocols (IQ, OQ, PQ, test method validation, design verification).

Perform tolerance analysis, CAD modeling (Creo / SolidWorks), and support prototype builds.

Conduct root cause analysis and implement design improvements.

Prepare and maintain design history file (DHF) documentation.

Partner with manufacturing to ensure smooth transfer of products into production.

Qualifications :

Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline.

3+ years of experience in medical device product development (Class II / III preferred).

Strong knowledge of design control, risk management, and regulatory requirements.

Hands-on experience with CAD software (Creo or SolidWorks).

Experience in DFMEA, tolerance analysis, and test method development.

Familiarity with biocompatibility, sterilization, and usability engineering is a plus.

Excellent problem-solving, documentation, and communication skills.