Medical Device Product Development Engineer
About the role
We are seeking an experienced Electrical/Electromechanical Engineer to support the development, testing, troubleshooting, and ongoing improvement of sophisticated medical devices. This position will focus on sustaining engineering, product reliability, design modifications, and technical problem-solving within a regulated manufacturing environment. The ideal candidate has a strong electrical engineering foundation, hands-on experience with complex electromechanical systems, and a background working with FDA-regulated medical devices. This is a Contract to Hire position based out of Sturtevant, WI. The position is anticipated to close on Oct 24, 2026. This is a hybrid position in Sturtevant, WI. This role operates within a regulated manufacturing environment. The candidate will engage with various technologies and equipment, collaborating with multidisciplinary teams to ensure product reliability and compliance.
Responsibilities
- Troubleshoot electrical and electromechanical product issues, conduct root cause investigations, and implement effective corrective actions.
- Support the development, maintenance, and continuous improvement of regulated medical devices throughout the product lifecycle.
- Conduct research, engineering evaluations, and testing to resolve technical challenges and improve product performance.
- Design, develop, and evaluate prototypes to verify functionality, safety, reliability, and compliance with product requirements.
- Create and maintain detailed electrical schematics, drawings, specifications, and engineering documentation.
- Execute Engineering Change Orders (ECOs) in accordance with established design controls, regulatory requirements, and internal procedures.
- Perform design verification and validation activities, document test results, and support product compliance.
- Collaborate with manufacturing, quality, regulatory, and engineering teams to resolve product and process issues.
- Support design improvements, component changes, and manufacturing process modifications.
Qualifications
- Bachelors degree in Electrical Engineering or a closely related engineering discipline.
- Minimum of 5 years of engineering experience developing or sustaining electromechanical products in a regulated environment.
- Experience developing or sustaining FDA-regulated medical devices.
- Familiarity with ISO, IEC, or related medical device standards.
- Experience with ultrasound, imaging systems, RF technology, or other energy-based medical devices.
- Familiarity with PCB assemblies, sensors, transducers, power electronics, and electromechanical integration.
Skills
- Strong foundation in electrical engineering.
- Experience troubleshooting electrical systems, analyzing failures, and implementing corrective actions.
- Ability to develop and interpret electrical schematics, engineering drawings, and technical specifications.
- Experience with design controls, engineering change management, and technical documentation.
- Hands-on experience with product testing, verification, and prototype evaluation.
- Strong problem-solving skills and ability to work across multidisciplinary engineering teams.
Pay
The pay range for this position is $70.00 - $80.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Benefits
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan
- Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)