Overview

Lead mechanical engineering strategy and execution for medical device products from concept through commercialization, ensuring designs are safe, manufacturable, reliable, and compliant with applicable regulatory requirements. This role owns key mechanical architecture decisions, mentors engineers, and partners cross-functionally to deliver robust, user-centered devices.

Responsibilities

• Own mechanical system architecture for medical device and research products.
• Translate user needs, industrial design intent, system requirements into engineering requirements and specifications and verifiable design outputs.
• Execute mechanical design and documentation in alignment with medical device regulatory requirements, including risk management and supporting regulatory submissions.
• Partner with cross-functional teams to deliver form, fit, comfort and aesthetics while meeting engineering, safety and compliance constraints.