Job Description

Job Title: Medical Device Engineer Responsibilities + Lead and manage critical activities related to maintaining and improving electro-mechanical medical device design, manufacturing, and service processes. + Participate in reliability studies and lead troubleshooting activities, investigating root causes to successful conclusions and resolving product complaints and CAPA. + Provide alternatives to end-of-life for electrical components. + Conduct research and testing to solve problems, ensuring functionality, safety, and effectiveness of devices. + Develop prototypes and conduct testing to ensure devices meet customer needs, design requirements, and regulatory standards. + Work closely with cross-functional teams, including mechanical engineers, process engineers, quality, and regulatory, to ensure device safety, compliance, compatibility, functionality, manufacturability, and serviceability. + Ensure compliance with relevant regulations and standards, such as FDA and IEC series. + Develop detailed electrical drawings and document design processes and test results. + Execute the Engineering Change Order (ECO) process per Design Controls - Design Change regulations and internal policies. Qualifications: + Bachelor's Degree in Electrical Engineering, Mechanical Engineering, other relevant Engineering discipline. + 7+ years Electrical engineering experience in a heavily regulated industry (e.g., automotive, medical). + Electrical engineering experience in the medical device industry. + Printed circuit board design and analysis experience and understanding. + Experience with Altium Designer or other electrical PCB design software. + Strong technical and problem-solving skills. + Ability to communicate and write effectively. + Emotional self-management in difficult situations. + Understanding of process validation and statistical analysis. + Understanding and application of ISO 13485 quality management system requirements. + Understanding of FDA Design Controls and EU Medical Device Directive (CE Marking requirements). Job Type & Location This is a Permanent position based out of Milwaukee, WI. Pay and Benefits 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 Workplace Type This is a hybrid position in Milwaukee,WI. Application Deadline This position is anticipated to close on Nov 17, 2025. About Actalent 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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Job Tags

Permanent employment, Remote work, 2 days per week,

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