Senior Mechanical Engineer – Catheter Devices (Hybrid)

Diversatek Healthcare; Milwaukee (WI); Hybrid; USD 90,000 - 150,000; Full time

Job summary

Diversatek Healthcare in Milwaukee, WI, is seeking a Senior Mechanical Engineer to drive catheter-based medical devices from concept through design transfer into validated production. This hybrid role spans new product development and manufacturing engineering, including design, process development, and on-floor validation in a regulated environment (FDA 21 CFR Part 820 and ISO 13485).

You will lead cross-functional teams, mentor junior engineers, coordinate with our Vietnam team, and own design

Qualifications

• BSME required in Mechanical Engineering.
• 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 with strong command of GD&T.
• Test and statistics: experience with Minitab, DOE, and capability analysis.
• Regulatory: working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971.
• Ownership: ability to lead technical workstreams independently, communicate clearly, and work with remote teams.

Responsibilities

• Design and develop catheter-based devices and components from concept through design transfer.
• Develop and optimize polymer processes and define process windows using DOE.
• Create 3D models and drawings with GD&T per ASME Y14.5.
• Author and execute IQ/OQ/PQ process validation protocols and reports; qualify new equipment.
• Develop test methods and fixtures; lead design verification and validation testing.
• Own design control deliverables including inputs/outputs, traceability, and DHF documentation.
• Lead ISO 14971 risk management activities (dFMEA/pFMEA).
• Support design transfer and early production; improve yield and process capability.
• Coordinate remotely with the Vietnam engineering team across time zones on design/tasks.
• Mentor junior engineers and serve as a technical resource.

Skills

Catheter design

Polymer processing

Process validation

DOE & statistics

GD&T

Inventor CAD

Tolerance analysis

Regulatory knowledge

Leadership

Education

Bachelor's degree in Mechanical Engineering

Tools

Autodesk Inventor

Minitab

Job description

Diversatek Healthcare in Milwaukee, WI, is seeking a Senior Mechanical Engineer to drive catheter-based medical devices from concept through design transfer into validated production. This hybrid role spans new product development and manufacturing engineering, including design, process development, and on-floor validation in a regulated environment (FDA 21 CFR Part 820 and ISO 13485).

You will lead cross-functional teams, mentor junior engineers, coordinate with our Vietnam team, and own design