Product Development Engineer III - Catheter Prototyping

Heraeus Group•Fridley, MN

40d•Onsite

About The Position

The primary responsibility of the Product Development Engineer III – Catheter Prototyping is to lead and execute catheter design and prototyping activities from early concept through prototype evaluation and design refinement. This includes translating customer needs into engineering requirements; generating and evaluating catheter concepts; developing 3D models and 2D engineering drawings; building, modifying, and troubleshooting catheter prototypes; and conducting bench-level testing of components, subassemblies, and complete devices. The Product Development Engineer III – Catheter Prototyping will work closely with cross-functional teams, customers, suppliers, and manufacturing partners to rapidly iterate designs and address technical challenges. The position will also support design verification, risk-based decision-making, documentation, and design transfer activities in accordance with Heraeus and customer quality systems. This is an onsite position in our Fridley, MN location, with movement between this and the White Bear Lake site as needed to support project activities.

Requirements

Bachelor’s degree in Engineering or related technical field is strongly preferred; Other relevant postsecondary education, training and experience may be considered in lieu of a Bachelor’s Degree.
Minimum 5 years of relevant engineering experience required; 1 year of relevant experience may be substituted for a graduate degree and 3 years for a doctorate.
Demonstrated experience designing and developing catheter-based medical devices or catheter components.
Hands-on experience building, modifying, troubleshooting, and evaluating catheter prototypes.
Experience with 3D CAD modeling, production-quality 2D engineering drawings, and engineering documentation.
Experience developing or executing bench-level test methods and using prototype and test data to guide design decisions.
Understanding of design controls and product development within a regulated quality system.
Demonstrated ability to solve complex technical problems, communicate recommendations clearly, and collaborate cross-functionally with engineering, quality, manufacturing, operations, suppliers, and customers.
Ability to move between Fridley and White Bear Lake sites, as needed to support project activities.

Nice To Haves

Experience with catheter materials, components, and manufacturing processes, including polymer tubing, wire, braid, coils, bonding, thermal forming, molding, extrusion, marker integration, shafts, tips, hubs, balloons, or steering/deflection features, preferred.
Experience with laboratory prototype tools, fixtures, benchtop test equipment, measurement systems, failure analysis, and root-cause investigation, preferred.
Experience with engineering analysis tools and methods such as DOE, statistical analysis, tolerance stack-ups, and Minitab, preferred.
Experience supporting design verification, design transfer, manufacturing scale-up, supplier development, or coaching and mentoring technical staff, preferred.

Responsibilities

Lead hands-on catheter prototype development from concept through evaluation, including prototype planning, component and device-level design, build execution, troubleshooting, design iteration, and performance assessment.
Translate customer needs, user requirements, and project objectives into measurable engineering requirements and prototype objectives, maintaining traceability among requirements, design outputs, prototype results, risks, and design decisions.
Generate, model, and evaluate catheter concepts at the component, subassembly, and full-device levels, including creation and maintenance of 3D CAD models, 2D engineering drawings, specifications, and prototype build documentation.
Select and evaluate materials, components, joining methods, and manufacturing approaches, and build or modify prototypes using appropriate catheter-development techniques, tools, fixtures, and laboratory equipment.
Develop and execute prototype test methods and bench setups to evaluate key performance characteristics, including dimensional performance, flexibility, torque response, trackability, push-ability, bond integrity, tensile strength, leak performance, and other program-specific requirements.
Analyze prototype and test data to identify failure modes and drive design decisions, using structured problem-solving and engineering methods such as tolerance stack-ups, material and component evaluations, design of experiments, and other data-driven analyses.
Support design verification and risk-management activities, including development and execution of verification plans, test protocols and reports, identification of design risks and failure modes, and establishment of critical-to-quality characteristics.
Plan and coordinate technical execution of development programs, including project plans, schedules, budgets, prototype builds, deliverables, and activities required to efficiently advance catheter concepts into further product development.
Collaborate with customers, technicians, suppliers, manufacturing partners, and cross-functional engineering teams to resolve technical, product, process, and prototype-build challenges; facilitate decisions regarding concept selection, prototype approaches, suppliers, and critical design characteristics; and clearly communicate technical results, risks, and recommendations.
Provide technical leadership and mentorship to less-experienced engineers in catheter design, prototyping, testing, and structured problem solving, while supporting other responsibilities as assigned.
Other duties may be assigned as required.