Pragmatic · 6 hours ago
Manufacturing Engineering Manager
Pragmatic is a growing medical device company entering a new phase following FDA approval of a novel embolization technology. They are seeking a Manufacturing Engineering Manager to lead manufacturing transfer activities while supporting live production and building scalable processes for the future.
Responsibilities
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
Qualification
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
Preferred
Experience in early-stage or startup medical device companies
Prior people leadership or player-coach experience
Familiarity with process validation and regulated manufacturing environments