Senior Director, Manufacturing and Operations
About The Position
At Lumicell, we'll give you the opportunity to harness all that's within you by working in a mission-driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery. We are working to revolutionize the way cancer surgery is performed today, starting with breast cancer. Women in the US have a 1 in 8 lifetime risk of being diagnosed with breast cancer. You will be a part of something groundbreaking as we expand our commercial launch and continue investigations in other cancer indications. Lumicell is seeking a Senior Director of Manufacturing and Operations to lead the management of outsourced manufacturing for a commercially approved, Class III fluorescence-guided surgery platform. This role serves as the primary point of contact for key contract manufacturing organizations (CMOs), manages a small internal team, and partners closely with Quality and R&D to ensure reliable supply, continuous improvement, and effective resolution of manufacturing and supplier quality issues.
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; self-motivated, hands-on, and comfortable with ambiguity
- Excellent problem-solving, troubleshooting, and cross-functional communication skills
Nice To Haves
- Experience with combination products (device + drug) and associated manufacturing or quality considerations
- Experience with electromechanical imaging systems, fluorescence imaging, or optoelectronics
- Production planning and budgeting experience
- Proven track record of driving COGS reduction and yield improvement programs at CMOs
- Experience with Class III medical devices and PMA-regulated products
- Exposure to FDA design controls, systems-level V&V, and design transfer activities
Responsibilities
- CMO & Supplier Management 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
- Quality System Support 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
- Team Leadership & Operations 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
11-50 employees
