Senior Mechanical Engineer - Medical Devices & Validation

Advanced Sterilization Products, Inc.; Irvine (CA); On-site; USD 101,000 - 169,000; Full time

Job summary

Advanced Sterilization Products is seeking a Senior Mechanical Engineer to plan and execute mechanical design for medical device systems and components. You will manage projects of moderate scope, create 3D models and drawings with GD&T, and drive verification and validation testing with cross-functional teams.

The role requires 10+ years of mechanical design experience in regulated industries, strong CAD skills, and a robust understanding of manufacturing and testing processes.

Qualifications

• Bachelor’s degree required in mechanical engineering or related field.
• 10+ years of mechanical design experience in regulated industry (7+ years with Master’s).
• Proven experience in design for manufacturing and testing.
• Ability to coordinate projects and influence cross-functional teams.
• Experience with GD&T, 3D modelling, and verification/validation.
• Travel both domestically and internationally as required.

Responsibilities

• Plan and conduct mechanical design and development for complex components and subsystems.
• Independently create and validate 3D models, drawings, and specifications with GD&T.
• Develop and execute test protocols; analyze results and propose design improvements.
• Lead design reviews and resolve complex technical issues.
• Execute and document verification and validation testing.
• Prepare technical documentation, proposals, and cost estimates.
• Collaborate across functions and with external partners to meet timelines.
• Apply FBS tools to optimize design processes and improve product quality.

Skills

GD&T principles

DFM

Problem solving

Communication

Electrical safety standards

MS Office/Visio

Collaboration

Project coordination

Cross-functional teams

Hand & lab tools

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

Job description

Advanced Sterilization Products is seeking a Senior Mechanical Engineer to plan and execute mechanical design for medical device systems and components. You will manage projects of moderate scope, create 3D models and drawings with GD&T, and drive verification and validation testing with cross-functional teams.

The role requires 10+ years of mechanical design experience in regulated industries, strong CAD skills, and a robust understanding of manufacturing and testing processes.