Medical Device Engineer Caledonia, WI

Medical Device Engineer job edonia, WI.

Lead the development of electromechanical medical device products, overseeing the process from design through to systems and quality assurance. This role requires a balance of onsite and remote work, with 3 days per week in the office in the Racine, Wisconsin area and 2 days working remotely.

• Lead and manage critical activities to maintain and improve electro‑mechanical medical device design, manufacturing, and service processes.
• Participate in reliability studies and lead troubleshooting activities to investigate root causes and resolve product complaints and CAPA.
• Provide alternatives to end‑of‑life for electrical components.
• Conduct research and testing to solve problems, testing functionality, safety, and effectiveness.
• Develop prototypes and conduct testing to ensure devices meet customer needs, design requirements, and regulatory standards.
• Collaborate closely with cross‑functional teams, including mechanical engineers, process engineers, quality, and regulatory teams, to ensure device safety, compliance, and functionality.
• Ensure device compliance with relevant regulations and standards, such as FDA, IEC series, and GMP.
• Develop detailed electrical drawings and document design processes and test results.
• Execute the Engineering Change Order (ECO) process according to Design Controls – Design Change regulations and internal policies.
• Support regulatory submissions and mentor junior electrical engineers.

• 10+ years of experience in electrical engineering with a focus on medical devices.
• Strong skills in root cause analysis and electrical design.
• Experience in quality assurance and systems engineering.
• Ability to address machine‑related and broader device or therapy‑related problems.

• Bachelor's Degree in Electrical Engineering.
• 7+ years of electrical engineering experience in the medical device field.
• Experience with printed circuit board design and analysis.
• Proficiency with Altium Designer or other electrical PCB design software.
• Understanding of process validation and statistical analysis.
• Knowledge of quality management system requirements.
• Understanding of FDA Design Controls and EU Medical Device Directive requirements.
• Familiarity with electro‑mechanical manufacturing, depot service, and field service processes and operations.
• Experience with system‑level requirements definition.

The role includes a hybrid work model with 3 days per week onsite at the office in Racine, Wisconsin and 2 days remote. The position involves collaboration with diverse teams and requires adherence to regulatory standards. The company offers a competitive annual bonus of up to 15%.

This is a Permanent position based out of Franksville, WI.

The pay range for this position is $110000.00 - $130000.00/yr.

Excellent benefits, 15% annual bonus and growing company and product in demand. Flexibility to work remotely 2 days/week.

This is a hybrid position in Franksville, WI.

This position is anticipated to close on Dec 26, 2025.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom for other accommodation options.