Manager, R&D Product Development Engineering

Job Overview

We are seeking an experienced R&D Product Development Manager to lead the design and development of polymer-based medical tubing, including heat shrink and extruded components, used in advanced medical devices and interventional therapies. This role combines hands-on technical leadership with cross-functional collaboration, guiding products from concept through design transfer and commercialization in a regulated (ISO 13485/FDA) environment.

The ideal candidate has a strong background in medical polymer extrusion, a deep understanding of thermoplastic and crosslinked materials, and a proven track record of launching Class I–III device components.

Key Responsibilities

• Lead R&D initiatives for extruded and heat shrink medical tubing, including multi-lumen, co-extrusion, and specialty configurations.
• Drive end-to-end product development: requirements definition, design input/output, prototyping, validation, and design transfer to manufacturing.
• Collaborate with cross-functional teams (Quality, Regulatory, Clinical, Manufacturing, Supply Chain) to ensure design feasibility, compliance, and scalability.
• Guide materials selection, tooling design, and extrusion process development with a focus on high-performance polymers.
• Develop and execute DOE, FMEA, and verification/validation protocols for tubing and assembly-level integration.
• Oversee generation of design history files (DHFs) and ensure alignment with ISO 13485, 21 CFR 820, and other applicable standards.
• Interface with OEM customers, contract manufacturers, and suppliers to support technical requirements and program timelines.
• Mentor and develop junior engineers and R&D technicians.

What your background should look like:

• Bachelor’s or Master’s degree in Materials Science, Biomedical Engineering, Polymer Science, Mechanical Engineering, or related discipline.
• Minimum 7+ years of experience in product development of medical device components, with a focus on polymer extrusion and heat shrink tubing.
• In-depth knowledge of thermoplastic processing, extrusion tooling, and crosslinking/expansion techniques.
• Demonstrated experience bringing medical tubing products from concept through design controls and commercialization.
• Strong working knowledge of biocompatibility, sterilization compatibility, and device testing (e.g., tensile, burst, kink, elongation).
• Familiarity with catheter-based technologies, vascular access, electrophysiology, or minimally invasive device applications is a plus.
• Excellent communication and leadership skills; ability to thrive in a fast-paced, collaborative environment.

Preferred Skills

• Experience working with Class II or III devices and implantable applications.
• Proficiency in statistical analysis tools (e.g., Minitab) and CAD tools for tooling design review.
• Previous exposure to design for manufacturability (DFM) and stage-gate development processes.

Competencies