Position Summary
The Senior Engineer, Catheter NPI & Manufacturing is responsible for leading the technical transfer, scale-up, and commercialization of complex catheter-based medical devices to external contract manufacturing organizations (CMOs). This role ensures successful product externalization through robust design transfer, process validation, and supplier integration. The individual will develop technical solutions to complex manufacturing challenges to ensure CMOs are fully qualified and scalable for commercial production.
Essential Duties and Responsibilities
Design Transfer & Externalization
- Lead end-to-end transfer of catheter products from R&D to established contract manufacturers, including planning, execution, and stabilization.
- Develop and own comprehensive technology transfer packages, including process flows, BOMs, work instructions, and equipment specifications.
- Ensure full alignment between the Design History File (DHF) and Device Master Record (DMR).
- Define transfer strategies, including build plans (alpha, pilot, validation, ramp) and success criteria.
- Establish manufacturing equivalency between internal development builds and CMO production.
Fixture & Tooling Development
- Design, develop, and qualify custom manufacturing fixtures and tooling for catheter assembly processes such as bonding, alignment, tipping, and reflow.
- Translate process requirements into fixture design specifications, including tolerance stack-ups and thermal considerations.
- Develop rapid prototype fixtures using 3D printing or machining to support engineering builds.
- Generate and maintain fixture documentation packages including drawings, BOMs, and maintenance requirements.
Process Development & Validation
- Transfer and scale manufacturing processes like bonding, shaft assembly, tipping, coating, and extrusion interfaces.
- Author and execute protocols and reports for design verification and validation, including shelf-life and performance testing.
- Lead process validation activities (IQ/OQ/PQ) at the CMO, including protocol development and report approval.
- Define and monitor critical process parameters (CPPs) and critical quality attributes (CQAs).
- Ensure implementation of process controls, in-line inspection methods, and SPC systems at the CMO.
Production Ramp & Performance Management
- Plan and execute engineering, pilot, and validation builds at the CMO.
- Provide on-site technical support during builds, including troubleshooting and operator training.
- Establish yield targets, scrap reduction plans, and ramp metrics.
- Drive resolution of build issues through structured root cause analysis such as DOE, 5-Why, and Fishbone.
- Serve as the primary technical interface between the organization and CMO engineering teams.
- Lead risk management activities, including PFMEA and control plans specific to CMO processes.
Experience & Qualifications
- Education: Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or a related field.
- Experience: 10+ years of experience in medical device engineering with a strong emphasis on NPI and design transfer.
- Technical Expertise: Deep expertise in catheter manufacturing processes and materials.
- Track Record: Proven success in product transfer to contract manufacturers, including validation and commercial ramp.
- Skills:
- Strong experience with process validation (IQ/OQ/PQ), DOE, and SPC.
- Working knowledge of CAD tools, specifically SolidWorks.
- Designing and implementing fixture-driven process solutions.
- Compliance: Strong understanding of FDA QSR, ISO 13485, and ISO 10555-1.
- Leadership: Demonstrated leadership in cross-functional environments; experience managing technical teams preferred.
Physical Requirements & Travel
- Travel: Regular travel is required.
- Environment: Includes sitting, standing, walking, and working in a factory environment near moving mechanical parts.
- Lifting: Ability to perform light to moderate lifting (50lbs or less).