Senior Mechanical Engineer

Diversatek Healthcare; Milwaukee (WI); Híbrido; USD 90.000 - 150.000; Tempo integral

Resumo da vaga

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Catheter design

Polymer processing

Process validation

DOE & statistics

GD&T

Inventor CAD

Tolerance analysis

Regulatory knowledge

Leadership

Formação

Bachelor's degree in Mechanical Engineering

Ferramentas

Autodesk Inventor

Minitab

Descrição da vaga

New Product Development & Manufacturing Engineering

Reports to: Vice President of Engineering

Employment type: Full-time, exempt

About Diversatek Healthcare

Diversatek, Inc. is a global, multi-platform healthcare solutions manufacturing company. Invested in a broad and ever-growing line of medical technologies, Diversatek manufactures and markets products and solutions for diagnostic and therapeutic procedures, continuing care and rehabilitation, and medical device OEMs.

Diversatek owns and operates manufacturing facilities in Wisconsin, Colorado, Virginia, and Saigon, Vietnam. Our Technical Research and Training Center in Denver, CO boasts a best-in-class clinical education and product training center for healthcare providers worldwide.

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.