Senior Engineer, Catheter NPI & Manufacturing

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