Principal Engineer / Senior Product Development Engineer – Medical Device R&D

Job Title: Principal Engineer / Senior Product Development Engineer Medical Device R&D
Location: California Onsite
Duration: 6 Months, with possibility of extension
Employment Type: Contract W2
Pay Rate: $50/hr(DOE) W2 Max

Job Summary:
We are seeking an experienced Principal / Senior Product Development Engineer to support hands-on R&D, product development, and sustaining engineering activities for disposable medical devices. This role requires a highly hands-on engineer who can independently drive engineering deliverables while performing prototype development, fixture design, device testing, troubleshooting, test method development, and verification activities in a laboratory environment.

The engineer will work cross-functionally with R&D, Manufacturing, Quality, and Regulatory teams and support products throughout development, commercialization, and sustaining/lifecycle activities.

Job Requirements:

• 7+ years of medical device industry experience

• Strong hands-on Medical Device R&D / Product Development Engineering experience

• Experience with disposable or single-use medical devices strongly preferred

• Advanced CAD/SolidWorks experience

• Hands-on fixture and tooling design experience

• Strong experience with prototype development, device testing, and troubleshooting

• Experience developing and executing test methods, protocols, and technical reports

• Product Verification & Validation (V&V) experience

• Working knowledge of Medical Device Design Controls and DHF documentation

• Experience supporting CAPAs, design/product changes, and sustaining engineering activities

• Experience with IQ/OQ of laboratory equipment, calibration, and preventive maintenance

• Knowledge of GMP/QMS-regulated environments

• Experience with engineering data analysis; DOE and ANOVA knowledge preferred

• Strong mechanical aptitude and hands-on problem-solving skills

• Ability to independently manage engineering deliverables, priorities, timelines, and project risks

• Strong technical writing, documentation, and presentation skills

• Experience collaborating with Manufacturing, Quality, and Regulatory teams

• Must be comfortable performing substantial hands-on laboratory work

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Bioengineering, Industrial Engineering, or a related technical discipline preferred