Senior Mechanical Engineer
New Product Development & Manufacturing Engineering
Company: Diversatek Healthcare
Location: Milwaukee, Wisconsin (on-site)
Department: Engineering
Reports to: Vice President of Engineering
Employment type: Full-time, exempt
The Role
We are looking for a Senior Mechanical Engineer to drive catheter-based medical devices from concept through design transfer and into robust, validated production. This is a hybrid role that spans new product development and manufacturing engineering: you will design the product, develop and characterize the processes that build it, and see it through validation on the manufacturing floor.
You will work in a regulated environment under FDA 21 CFR Part 820 and ISO 13485, serve as a technical lead on cross-functional project teams, and collaborate closely with Quality, Regulatory, Operations, and our engineering team in Vietnam.
What You'll Do
• Design and develop catheter-based devices and components, including balloons, shafts, tips, and handle assemblies, from concept through design transfer.
• Develop and optimize devices and components for polymer processes such as injection molding, extrusion, balloon forming, bonding, tipping, and catheter assembly; define process windows using DOE and statistical analysis.
• Create 3D models, detailed drawings, and tolerance stack-ups applying GD&T per ASME Y14.5.
• Author and execute process validation protocols and reports (IQ/OQ/PQ), and specify, qualify, and implement new manufacturing equipment and tooling.
• Develop test methods and fixtures, lead test method validation, and plan and execute design verification and validation testing.
• Own design control deliverables including design inputs/outputs, traceability, design reviews, and DHF documentation.
• Lead risk management activities per ISO 14971, including dFMEA and pFMEA.
• Support design transfer and early production, resolving technical issues and driving yield and process capability improvements.
• Coordinate remotely with the Vietnam engineering team across time zones on design, process, and documentation tasks.
• Mentor junior engineers and technicians and serve as a technical resource across the department.
What You Bring
• Education: Bachelor's degree in Mechanical Engineering (BSME) required.
• Experience: 5-10 years of engineering experience in medical devices or another regulated industry.
• Catheter and polymer processing: hands-on experience with catheter design, balloon forming, extrusion, or related polymer processes.
• Process validation: demonstrated experience authoring and executing IQ/OQ/PQ protocols and reports.
• CAD and tolerancing: proficiency in Autodesk Inventor (or equivalent) with strong command of GD&T and tolerance analysis.
• Test and statistics: experience with test method development, design verification, and statistical tools such as Minitab, DOE, and capability analysis.
• Regulatory: working knowledge of design controls under 21 CFR Part 820, ISO 13485, and risk management under ISO 14971.
• Ownership: ability to lead technical workstreams independently, communicate clearly in writing, and work effectively with remote, cross-cultural teams.
