Manufacturing Engineering Manager

Medical Device | Commercialization & Manufacturing Transfer

We’re a growing medical device company entering an exciting new phase following FDA approval of a novel embolization technology. The organization is transitioning from clinical-stage development into full commercialization, including a manufacturing facility move and multiple process transfers.

This is a pivotal moment for the business — and manufacturing engineering plays a central role.

We’re hiring a Manufacturing Engineering Manager to lead and execute manufacturing transfer activities while supporting live production and building scalable processes for the future.

This is a player-coach role
. You’ll lead a small team while staying hands-on — solving problems on the floor, working cross-functionally, and owning outcomes.

If you enjoy rolling up your sleeves, operating close to the product, and making real decisions that directly impact patients and production, this role will suit you well.

• Lead manufacturing process transfers, including facility moves
• Own transfer strategy, readiness planning, and execution timelines
• Serve as the technical point of accountability during transfer and ramp-up

• Support live manufacturing as needed, troubleshooting issues and driving improvements
• Establish and track manufacturing metrics (yield, process capability, performance)
• Partner closely with Supply Chain and Production teams

• Lead and mentor a small manufacturing engineering team (currently 1 engineer)
• Act as a hands-on technical leader with credibility on the floor

• Work closely with Quality, Regulatory, R&D, Supply Chain, and Production
• Support process validation activities and documentation
• Improve processes, documentation, and manufacturing readiness as the company scales
• Help define manufacturing engineering best practices for an early commercial environment

• Medical device manufacturing processes that are largely manual (not heavily automated)
• Biomaterials and non-traditional med-tech processes
• A growing commercial organization where engineering decisions have immediate impact

Required

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or similar
• Experience in medical device manufacturing engineering
• Hands-on experience with manufacturing transfer, scale-up, or facility moves
• Strong communication skills and ability to work cross-functionally

• Experience in early-stage or startup medical device companies
• Prior people leadership or player-coach experience
• Familiarity with process validation and regulated manufacturing environments

• Critical growth phase
  : commercialization + facility transition
• Real ownership
  : lead transfer strategy and execution end-to-end
• Visible impact
  : decisions directly affect production and patient outcomes
• Culture
  : practical, low-ego, collaborative, and execution-focused

This role is ideal for someone who wants to build, transfer, and scale manufacturing — not just maintain what already exists.