Product Development Engineer III Catheter Prototyping

Position Summary

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.

What Youll Do Every Day:

• 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.

What Were Looking For:

• Bachelors degree in Engineering or related technical field is strongly preferred; Other relevant postsecondary education training and experience may be considered in lieu of a Bachelors 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.
• 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.
• Ability to move between Fridley and White Bear Lake sites as needed to support project activities.

Medevio is committed to providing competitive total compensation and benefits packages. The expected hiring range for this position is between $100000.00 and $117000.00 based upon a full-time schedule. This is a good faith estimate on the applicable salaries are determined by taking a variety of factors in account including but not limited to candidate qualifications geographic locations market conditions and internal position is bonus eligible with a target bonus of 10%.Our total compensation package includes eligibility for comprehensive medical dental and vision coverage a 401(k) plan with company match education reimbursement paid parental leave and paid time off.