Our client, an innovative medical device company, is seeking a Senior Engineer, Catheter NPI & Manufacturing to lead the transfer, scale-up, and commercialization of catheter-based products to contract manufacturers (CMOs). This role will be instrumental in ensuring successful externalization of manufacturing through robust design transfer, process validation, and supplier integration.
Essential Duties & Responsibilities
Design Transfer & CMO Externalization
- Lead end-to-end transfer of catheter products from R&D to contract manufacturers, including planning, execution, and post-transfer stabilization
- Develop and own comprehensive technology transfer packages (process flows, BOMs, work instructions, equipment specs, test methods, training materials)
- Ensure alignment between design history and manufacturing documentation
- Define transfer strategy (alpha, pilot, validation, ramp) and success criteria
- Establish manufacturing equivalency between development and production
Manufacturing Fixture & Tooling Development
- Design and qualify custom fixtures/tooling for catheter assembly (bonding, alignment, tipping, reflow)
- Translate process requirements into fixture design specs (tolerances, alignment, thermal considerations, operator interaction)
- Support rapid prototyping and transition to production-ready tooling
- Maintain fixture documentation and ensure scalability/repeatability
CMO Readiness & Qualification
- Partner cross-functionally to support CMO onboarding and qualification
- Execute technical capability assessments and gap closure plans
- Define equipment, tooling, and infrastructure requirements
- Support first article inspection (FAI) and process qualification readiness
- Ensure compliance with FDA, ISO, and internal quality standards
Process Development, Industrialization & Validation
- Transfer and scale catheter manufacturing processes to CMO environments
- Author and execute design verification/validation and process validation (IQ/OQ/PQ)
- Define and monitor critical process parameters (CPPs) and quality attributes (CQAs)
- Implement process controls, inspection methods, and SPC systems
- Drive process robustness and repeatability
Build Execution & Production Ramp
- Plan and execute engineering, pilot, and validation builds
- Provide on-site technical support, troubleshooting, and training
- Establish yield targets, scrap reduction plans, and ramp metrics
- Drive root cause analysis and issue resolution
- Transition ownership to sustaining teams post-launch
Supplier & CMO Performance Management
- Serve as primary technical interface with manufacturing partners
- Establish and monitor KPIs (yield, cycle time, cost, quality)
- Lead continuous improvement and value engineering initiatives
- Support investigations (NCR, CAPA, deviations)
- Drive change management implementation
Cross-Functional Leadership & Compliance
- Partner with Quality, Regulatory, and Supply Chain
- Support audits and regulatory submissions
- Lead risk management activities (PFMEA, control plans)
- Ensure compliance with design control and quality systems
Documentation & Systems
- Develop and maintain manufacturing documentation and training materials
- Ensure traceability between design, process, and inspection
- Review and approve partner-generated documentation
Experience & Qualifications
- Bachelor’s degree in Engineering or related field
- 10+ years of medical device experience with emphasis on NPI, design transfer, and CMO execution
- Strong experience with catheter manufacturing processes
- Proven success transferring products to CMOs through validation and commercialization
- Expertise in process validation (IQ/OQ/PQ), DOE, SPC
- Experience with global suppliers and manufacturing partners
- Proficiency with CAD tools (e.g., SolidWorks)
- Strong knowledge of FDA QSR and ISO 13485
- Experience supporting audits and regulatory submissions
- Demonstrated cross-functional leadership
