Director of Manufacturing

Job Responsibilities:

• Own the technical and process side of the CMO relationship: technology transfer, process development, and process validation strategy (IQ/OQ/PQ), ensuring processes are robust, transferable, and audit-ready
• Lead NPI from R&D design handoff through CMO production ramp, translating design intent into manufacturable, CMO-executable work instructions and process specs
• Own mfg. process KPIs (yield, scrap, first-pass quality, process capability) and drive corrective action at the process level when performance drifts
• Drive Lean Manufacturing and Six Sigma initiatives across the CMO network: waste reduction, process capability improvement, and continuous improvement programs at partner sites
• Partner with Supply Chain on capacity planning, production scheduling, and single-source risk mitigation, providing the technical input that informs sourcing and dual-sourcing decisions
• Conduct regular CMO site visits for floor-level process troubleshooting and technology transfer execution
• Partner closely with the COO on R&D priorities, resourcing, and roadmap execution
• Lead design transfer governance: define the stage-gate criteria a design must meet before release to a CMO for production
• Serve as the bridge between R&D and manufacturing, resolving design-for-manufacturability issues before they become process nonconformances
• Flag process drift or capability concerns at CMO sites to Quality between periodic audits, supporting root cause from the manufacturing/process side
• Support technology transfer and validation documentation that feeds CMO qualification and requalification, which Quality owns
• Provide technical/process input into CMO capacity, scheduling, and sourcing decisions owned by
• Collaborate on single-source risk assessments, contributing the process-transferability view to dual-sourcing decisions
• Build long-term manufacturing strategy as the company scales: when to add CMOs, when to bring select processes in-house, and how to structure the network for growth

Job Requirements:

• 10+ years in medical device manufacturing/process engineering, including experience managing production through contract manufacturers rather than owned facilities
• Strong management/leadership experience
• Track record leading CMO technology transfer and process validation at a strategic level
• Lean Manufacturing and Six Sigma expertise (Green or Black Belt preferred), with demonstrated experience driving process improvement and waste reduction at CMO sites
• Working fluency in ISO 13485 and 21 CFR Part 820/QMSR
• Comfortable operating at both strategic (network strategy, executive reporting) and tactical (protocol review, floor-level CMO troubleshooting) altitude
• Strong cross-functional collaborator; this role sits at the intersection of R&D, Quality, and Supply Chain without owning any of those functions outright