Staff Mechanical Engineer

What You’ll Do

Mechanical Design

Lead the mechanical design of implantable and external medical device subsystems.

Generate detailed CAD models, drawings, and manufacturing documentation.

Build, assemble, and evaluate mechanical prototypes to rapidly iterate designs and reduce technical risk.

Evaluate design concepts, perform tolerance analyses, and participate in design reviews.

Collaborate with manufacturing partners and external vendors to optimize designs for manufacturability and reliability.

Design Verification & Validation

Develop comprehensive mechanical verification strategies for implantable and external systems.

Analyze verification data, identify failure modes, and recommend design improvements.

Author verification plans, protocols, acceptance criteria, reports, and traceability documentation.

Develop mechanical test methods consistent with applicable medical device standards.

Execute and analyze verification testing including tensile, compression, fatigue, vibration, environmental, durability, and functional testing.

Investigate failures, perform root cause analysis, and drive corrective design improvements.

Support design validation activities and clinical readiness.

Test Equipment & Fixture Development

Design and develop custom mechanical test fixtures and tooling to support design verification activities.

Improve the efficiency and repeatability of mechanical testing through fixture design and standardized test methods.

Own and operate mechanical test equipment, including universal testing machines (e.g., Instron), force gauges, and torque testers.

Product Development

Participate in requirements development, risk analysis, design reviews, and design control activities.

Support prototype builds, engineering evaluations, and design iterations throughout the product development lifecycle.

Support transition from prototype through manufacturing and production.

Generate Design History File documentation supporting regulatory submissions.

Work closely with contract manufacturers to resolve design and manufacturing issues.

Cross-Functional Leadership

Serve as the primary mechanical engineering resource within the Testing organization.

Collaborate with Hardware, Firmware, Quality, and Regulatory throughout product development.

Provide technical leadership for mechanical verification activities.

Mentor junior engineers and establish best practices for mechanical design and testing.

Qualifications

Bachelor's degree in Mechanical Engineering, or related field.

8+ years of mechanical engineering experience developing medical devices.

Extensive experience designing precision mechanical systems.

Strong proficiency using SolidWorks (or equivalent professional CAD software).

Experience developing products under FDA Design Controls and ISO 13485.

Experience developing verification protocols, reports, and mechanical test methods.

Strong understanding of mechanical testing principles, including fatigue, durability, environmental, and reliability testing.

Experience supporting design verification activities.

Experience developing custom test fixtures and automated laboratory equipment.

Excellent written and verbal communication skills.