Process Development Engineer (catheter)

Lead catheter design from concept to manufacturable product in a direct-hire role with competitive pay. Product Development Engineer (catheter) — full-time, on-site in Maple Grove, MN. Direct hire; salary $85k–$140k DOE. Drive feasibility, design, prototyping, process development, verification, and transfer to manufacturing. - Bachelor’s in ME/BME (Master’s preferred) - 5+ years catheter design experience (braided shafts, steerable systems) - Proficiency in CAD and engineering documentation - Knowledge of catheter materials and medical device design controls - Experience with DFMEA/PFMEA and regulated environments

Our client is seeking a Catheter Development Engineer with a strong background in catheter design to lead the translation of customer-provided inputs into robust engineering specifications, product designs, and manufacturable solutions.  Client will consider all levels of experience.

This role will take conceptual requirements for catheter-based devices and drive them through feasibility, design, prototyping, process development, and verification ensuring designs meet performance, regulatory, and manufacturability requirements.

This is a direct hire role!  

Job Title:  Product Development Engineer
Location:  Maple Grove, MN
Salary:  85-140k, depends on experience

Key Responsibilities

• Translate customer requirements into detailed engineering specifications and design inputs
• Lead the design and development of catheter-based devices, including braided shafts and steerable systems
• Develop design concepts, perform trade-off analyses, and create detailed drawings and documentation
• Drive prototype builds, process development, and iterative design refinement
• Define and execute verification testing to ensure product performance and compliance
• Collaborate closely with customers, manufacturing, quality, and regulatory teams
• Support risk management activities (DFMEA/PFMEA) and design controls documentation
• Identify opportunities to improve performance, manufacturability, and cost
• Provide technical leadership on complex catheter development programs

Qualifications
Required:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field (Master’s preferred)
• 5+ years of hands-on experience in catheter design and development (will consider all levels)
• Strong background in braided shafts, steerable catheters, and complex delivery systems
• Experience converting customer inputs into formal engineering requirements and specifications
• Knowledge of materials commonly used in catheter construction (e.g., polymers, braids, hypotubes)
• Experience with medical device design controls and regulated environments
• Proficiency in CAD and engineering documentation

Preferred:

• Experience in structural heart, neurology, EP, ENT, or cardiology applications
• Hands-on prototyping and process development experience
• Familiarity with extrusion, braiding, reflow, tipping, bonding, and assembly processes