Lead Design Engineer

We are partnering with a growing medical device manufacturer seeking a Design Engineering Supervisor to lead product development initiatives for surgical devices. This individual will guide projects from early concept through commercialization, ensuring designs meet performance, regulatory, and manufacturability expectations.

This position blends hands‑on engineering with team leadership and cross‑functional collaboration. The ideal candidate thrives in regulated environments and enjoys solving complex mechanical challenges while mentoring engineers.

• Drive new product development and design enhancements through all phases of the design control process
• Translate user and business requirements into practical, manufacturable design solutions
• Lead engineering reviews and ensure milestone achievement

• Oversee detailed mechanical analysis including FEA, fatigue analysis, risk assessments, and design for manufacturability
• Guide prototype development, testing, and validation activities
• Support process improvements related to automation, sterilization compatibility, and biocompatibility

• Ensure compliance with FDA Quality System Regulations (21 CFR Part 820 / QMSR) and ISO 13485
• Support documentation accuracy including design history files and device records
• Participate in non‑conformance investigations, MRB activities, and root cause analysis for field issues

• Provide day‑to‑day guidance and mentorship to the engineering team
• Assign priorities and monitor timelines to keep projects on track
• Collaborate with Quality, Manufacturing, and Regulatory teams to resolve technical roadblocks

• Bachelor’s degree in Mechanical, Biomedical, Materials Engineering, or related discipline
• 5+ years of medical device product development experience
• Strong proficiency in Solid Works and 3D CAD modeling
• Experience designing mechanical components and assemblies, including metals and/or reusable surgical instruments preferred
• Background in prototyping, product testing, and structured problem‑solving methodologies
• Understanding of risk management, design verification/validation, and regulated product lifecycle processes
• Strong communication skills with the ability to work across multiple teams