Senior Engineer, Catheter NPI & Manufacturing

Senior Engineer, Catheter NPI & Manufacturing at Mosaic People Solutions Senior Engineer, Catheter NPI & Manufacturing at Mosaic People Solutions in Poway, California Posted in 2 days ago.

Type:

full-time

Job Description:

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