Sr Catheter Engineer

Salary Range:$150,000.00 To $160,000.00 Annually

Compensation: Salary range commensurate with experience and qualifications.

Role Overview

Arrotek USA is seeking an experienced Sr. Catheter Engineer specializing in catheter and guidewire design and process development. Arrotek is not a traditional OEM; we are a premier

Design and Manufacturing partner that provides finished products and innovative concepts directly to our global customers.

As a Subject Matter Expert (SME) in interventional processes, this position is responsible for the design, development, and commercialization of advanced medical devices. The role involves managing the full product lifecycle,from initial concept through to finished, market-ready products. Requirements include significant technical depth in design-for-manufacturing and the professional communication skills necessary for a fast-paced, fee-for-service design environment."

Key Responsibilities

• Concept to Completion: Drive the full lifecycle of medical device development, from innovative concept generation and prototyping to final process development and design transfer.
• SME Leadership: Serve as the Subject Matter Expert for guidewire and catheter interventional processes, providing technical guidance on complex design challenges.
• Innovative Design: Develop creative design concepts using 3D modeling (SolidWorks), drafting, and rapid prototyping to meet specific client needs.
• Process Development: Design, optimize, and document manufacturing and assembly processes. Execute Design of Experiments (DOE), verification, validation, and process characterization.
• Hands-on Prototyping: Build prototypes and perform bench testing to evaluate device performance and "manufacturability."
• Documentation: Maintain high-quality engineering documentation, including DHF records, specifications, and verification protocols in compliance with FDA and ISO 13485 standards.
• Client Collaboration: Work closely with external clients to translate their vision into a functional, finished product, managing project records and time-and-materials efforts.
• Design Transfer: Seamlessly transfer designs and processes from the R&D stage into full manufacturing environments.

Required Qualifications

• Experience: 5 years (Senior level) of hands-on experience in catheter, guidewire, or minimally invasive medical device development.
• SME Expertise: Proven track record as a Subject Matter Expert in interventional processes and guidewire/catheter fabrication.
• Education: Bachelor’s or Master’s degree in Biomedical, Mechanical, Manufacturing, or Polymer Engineering.
• Technical Skills: Deep knowledge of fabrication techniques: catheter assembly, reflow, UV/solvent bonding, extrusion, tipping, grinding, and small-component assembly.
• Design-to-Manufacturing Mindset: Experience in a design-manufacturing environment where the goal is delivering a finished concept or product to a customer.
• Software: Proficiency with 3D CAD (SolidWorks).
• Regulatory: Working knowledge of FDA regulations, Design Control processes, and GMP.

Preferred Skills

• Materials Science: Experience with Pebax, Nylon, PTFE, FEP, PEEK, Nitinol, and Stainless Steel.
• Client Management: Experience in a "Design Services" or consulting-style engineering role.
• Mentorship: Ability to lead junior engineers and drive technical excellence across the team.
• Precision: Strong problem-solving skills with high attention to detail in a regulated environment.

Work Environment

Hands-on laboratory and manufacturing environment requiring fine motor skills to manipulate small components. Ability to sit or stand for extended periods during prototyping and testing.

Why Join Us

At Arrotek USA, we don’t just ship inventory; we deliver care. As a design manufacturer, we offer:

• Diversity of Projects: Work on a wide array of innovative concepts for different global clients.
• Impact: See your designs move from a "blank sheet of paper" to a finished product used in life-saving procedures.
• Growth: Be a part of a rapidly expanding Design Services organization with a collaborative culture.

"Healthcare that is both high-tech and human, with a global reach but a personal impact."