Senior Director, Manufacturing and Operations
Lumicell
full-time
Posted on:
Location Type: Hybrid
Location: Waltham • Massachusetts • United States
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Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
manufacturing engineeringproduction schedulingcapacity planningyield improvementCOGS reductionsupplier qualificationquality system activitiesdesign for manufacturabilityproject managementbudget management
Soft Skills
communicationteam managementcollaborationproblem-solvingleadershiporganizational skillsanalytical skillsadaptabilityentrepreneurial mindsetrelationship management