Mechanical Engineer

Job Title: Mechanical Engineer
Location: CA 100% Onsite
Duration: 6 12+ Months
Payrange:$40-$45/hr(DOE)

We are looking for a Mechanical/Product Development Engineer to support R&D and product development for cardiovascular/vascular closure medical devices.

Key Responsibilities:

• Lead mechanical design, product development, and sustaining engineering activities.

• Develop prototypes, fixtures, and test methods using SolidWorks/CAD.

• Perform hands-on device testing, troubleshooting, and bench testing.

• Support Design Controls, DHF, V&V, CAPA, and design changes.

• Apply DOE, ANOVA, and statistical analysis to engineering studies.

• Collaborate with R&D, Quality, Regulatory, and Manufacturing teams.

• Support FDA, QMS, and GMP requirements.

Required Qualifications:

• 7+ years of medical device industry experience.

• Strong SolidWorks/CAD and mechanical design experience.

• Experience with medical device testing, prototyping, Design Controls, and V&V.

• Knowledge of FDA, QMS, GMP, DOE/ANOVA.

• Cardiovascular, catheter, vascular closure, or disposable medical device experience preferred.