Serve as the primary point of contact for key contract manufacturers across a multifaceted device program (optical imaging probe, cart system, and sterile disposables)
Manage day-to-day CMO relationships, including production scheduling, capacity planning, yield improvement, and COGS reduction initiatives
Drive manufacturability improvements and design-for-manufacturing trade-offs in collaboration with R&D engineering
Oversee supplier qualification, incoming inspection requirements, and component-level quality issues
Coordinate the procurement planning and budgeting between Lumicell and contract manufacturing partners
Direct and support technical investigations and corrective actions in support of NCMRs, CAPAs, and Complaints
Collaborate with Quality to ensure manufacturing-related nonconformances are dispositioned promptly and root causes are addressed at the supplier level
Drive supplier corrective actions (SCARs) and monitor effectiveness of implemented corrections
Support internal and external audits related to manufacturing and supplier quality
Build and manage a small internal team responsible for supplier management, manufacturing engineering support, and continuous improvement
Maintain project timelines and communicate manufacturing and operations status to company leadership
Develop and manage operational budgets, project costs, and production forecasts
Support the transition of design changes and next generation products through pilot builds and into sustained commercial manufacturing at contract manufacturers
Contribute to design controls documentation and verification/validation activities as needed to support PMA supplements and design changes
Requirements
Bachelor’s degree in an engineering discipline with 12+ years of experience in the medical device industry; mechanical or manufacturing engineering preferred
Significant experience managing outsourced manufacturing operations, including direct oversight of contract manufacturers for regulated medical devices
Demonstrated experience as a primary CMO point of contact, with a track record of managing production quality, capacity, and cost targets
Hands-on experience supporting quality system activities including NCMR, CAPA, Complaint investigations, and supplier corrective actions
Experience managing or building a small team of engineers and/or manufacturing operations professionals
Strong knowledge of manufacturing techniques, materials, tolerancing, and design for manufacturability
Familiarity with ISO 13485 and IEC 60601-1
Ability to operate effectively in a small-company, entrepreneurial environment