Sr Catheter Engineer

Theragenics Corp•Sandwich, MA

10d

About The Position

Arrotek USA is seeking an experienced Sr Catheter Engineer specializing in catheter and guidewire design and process development. In this pivotal role, you will support the design, development, and commercialization of advanced interventional medical devices. This position is part of a rapidly growing Design Services organization and requires a hands-on engineer with strong technical depth, problem-solving ability, and client-facing communication skills. You will be involved in every stage of the medical device lifecycle — from concept development and prototyping to process development, verification/validation, and design transfer. Collaboration with cross-functional teams and external clients in a fast-paced, fee-for-service environment is central to this role.

Requirements

Bachelor’s or Master’s degree in Biomedical, Mechanical, Manufacturing, Plastics, Polymer Engineering, or related discipline.
3+ years of hands-on experience in catheter, guidewire, or minimally invasive medical device development.
Strong knowledge of fabrication and assembly techniques (catheter assembly, reflow, UV/solvent bonding, extrusion, tipping, machining, grinding, small-component assembly).
Experience developing prototypes and novel process technologies.
Proficiency with 3D CAD (SolidWorks) and Microsoft Office tools.
Working knowledge of FDA regulations and Design Control processes.
Strong technical writing and documentation skills.
Excellent communication skills, including client-facing interaction.
Ability to work independently while managing multiple priorities.

Nice To Haves

Experience with catheter and guidewire materials (Pebax, Nylon, PTFE, FEP, PEEK, Nitinol, Stainless Steel).
Experience in regulated manufacturing environments (ISO 13485).
Exposure to precision manufacturing in non-medical industries.
Leadership or mentoring experience.
Strong problem-solving skills with high attention to detail.

Responsibilities

Design and develop innovative catheter and guidewire technologies, including concept generation, modeling, drafting, and prototyping.
Develop, optimize, and document manufacturing and assembly processes for catheter-based devices.
Execute Design of Experiments (DOE), verification, validation, and process characterization activities.
Build prototypes and perform bench testing to evaluate device performance.
Create and maintain engineering documentation (specifications, test methods, verification protocols, reports, DHF records).
Transfer designs and processes from R&D into manufacturing environments.
Ensure compliance with FDA regulations, ISO standards, GMP, and Design Control requirements.
Collaborate with vendors and suppliers to source components and materials.
Manage project records, track time-and-materials efforts, and prepare technical reports.
Contribute to intellectual property development related to device design and process technologies.
Provide technical leadership, mentor junior engineers, and communicate effectively with clients.