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Job description
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
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.