Senior Director, Manufacturing and Operations

Role Overview

• 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

Benefits

• Health insurance
• 401(k) matching
• Flexible work arrangements