CMO Manufacturing & Process Transfer Lead

RedBrick Staffing; California (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

RedBrick Staffing seeks an experienced Manufacturing/Process Engineer to own technical transfer and validation strategy with contract manufacturers, and to lead NPI from design handoff through ramp to production.

You will drive Lean and Six Sigma initiatives across the CMO network, optimize process KPIs, and collaborate with Supply Chain, Quality, and R&D to ensure scalable, audit-ready processes for growth.

Qualifications

• 10+ years in medical device manufacturing/process engineering or equivalent.
• Experience leading technology transfer and process validation at a strategic level.
• Lean Manufacturing and Six Sigma expertise with demonstrated waste reduction at CMOs.
• Fluency with ISO 13485 and regulatory requirements (21 CFR Part 820/QMSR).
• Ability to operate at both strategic and tactical levels (network strategy to floor troubleshooting).

Responsibilities

• Own the technical and process side of the CMO relationship: technology transfer, process development, and process validation strategy (IQ/OQ/PQ).
• Lead NPI from R&D design handoff through CMO production ramp with manufacturability in mind.
• Own KPIs like yield, scrap, first-pass quality, and process capability; drive corrective actions.
• Lead Lean/Six Sigma initiatives across CMO network for waste reduction and capability improvements.
• Partner with Supply Chain on capacity planning, scheduling, and risk mitigation.
• Conduct regular CMO site visits for troubleshooting and transfer execution.
• Collaborate with COO on R&D priorities, resourcing, and roadmaps.
• Lead design transfer governance and release criteria to CMOs for production.
• Resolve design-for-manufacturability issues with R&D and manufacturing.
• Flag process drift to Quality with root cause analysis support.
• Support technology transfer and validation documentation feeding CMO qualification.

Skills

CMO collaboration

Process transfer

Lean Manufacturing

Six Sigma

ISO 13485

21 CFR 820

Cross-functional collaboration

IQ/OQ/PQ

Tools

IQ/OQ/PQ

Job description

• 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
• 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