Mechanical Engineering Manager

About the Role

Responsibilities

• Lead, hire, and develop a team of 3 to 5 mechanical and product engineers, setting clear expectations, giving direct feedback, and managing performance.
• Run day-to-day technical project execution: clear roadblocks, resolve resource conflicts, and hold the team to its commitments and schedules.
• Own the Design History File and related design control documentation for your products, including design transfer to production, in compliance with our quality system (21 CFR 820 and ISO 13485).
• Participate in high-level product definition and design requirement decisions and translate them into detailed project plans for new products, product improvements, and DFX changes.
• Lead design reviews and review engineering work for technical accuracy, making sure designs account for manufacturing, quality, regulatory, and clinical requirements.
• Guide the team through root cause analysis and problem solving on design issues, from prototype and verification testing through production.
• Support product initiatives driven by RA/QA, Supply Chain, and Operations, such as design changes for supplier transitions, CAPAs, and cost or yield improvements.
• Partner with Manufacturing, Quality, and commercial teams to drive product improvements and new product launches.

Qualifications

• Bachelor's degree in mechanical engineering, electrical engineering, or a related engineering discipline.
• 8+ years of overall experience, including leading development teams through complex technical projects.
• Proven experience managing or mentoring engineers.
• Led at least one project end to end with full ownership of the outcome.
• Demonstrated experience bringing a product from initial concept development through transfer to production.
• Strong grasp of design controls and Design History File ownership in a regulated environment.
• Strong communication and problem-solving skills, including root cause analysis and analytical thinking, with close attention to detail.
• Ability to prioritize, delegate, and hit deadlines through a team while keeping people energized and aligned on a shared goal.
• Experience with electromechanical medical devices, surgical instruments, or Class II devices is a plus.
• What Success Looks Like
• By 3 to 6 months: you have built working relationships with each engineer and your cross-functional partners, taken ownership of your team's project plans and DHF, and have run design reviews the team finds useful.
• By 1 year: your team is consistently delivering on its commitments, you have hired or grown engineers who raise the team's bar, and at least one product improvement or new product has moved forward on schedule under your leadership.
• What makes someone excellent: they stay technically sharp enough to challenge a design, give engineers room to own their work, and catch cross-functional problems before they reach production.
• Location & Work Arrangement
• This position is based at our headquarters in Bedford, Massachusetts, in the Greater Boston area, and is an on-site role.
• Visit our Candidate Journey page to learn what to expect from our hiring process.
• Salary Range
• $125,000 — $175,000 USD