Senior Medical Device Electrical Engineer - Sustaining

Actalent; Racine (WI); Hybride; USD 96 000 - 110 000; Plein temps

Avantages offerts par ce poste

Résumé du poste

Actalent is seeking an experienced Electrical/Electromechanical Engineer to support development, testing, troubleshooting, and ongoing improvement of medical devices in a regulated manufacturing environment. This role focuses on sustaining engineering, design modifications, and problem-solving within FDA-regulated contexts.

The candidate should have a strong electrical engineering foundation, hands-on experience with complex electromechanical systems, and familiarity with ISO/IEC medical device

Qualifications

• 5+ years of engineering experience in electromechanical products within a regulated environment.
• Experience developing or sustaining FDA-regulated medical devices.
• Strong electrical engineering foundation with hands-on testing and prototyping.
• Familiarity with ISO/IEC medical device standards.

Responsabilités

• Troubleshoot electrical and electromechanical product issues, conduct root cause investigations, and implement corrective actions.
• Develop, maintain, and improve regulated medical devices throughout the product lifecycle.
• Design, test, and evaluate prototypes to verify functionality, safety, and reliability.
• Create and maintain detailed schematics, drawings, specifications, and documentation.
• Execute ECOs following design controls and regulatory requirements.
• Perform design verification and validation, document results, and support compliance.
• Collaborate with manufacturing, quality, regulatory, and engineering teams to resolve issues.
• Support design improvements and manufacturing process modifications.

Connaissances

Electrical engineering

Electromechanical systems

FDA-regulated devices

Root cause investigations

Engineering documentation

Formation

Bachelor's degree in Electrical Engineering

Description du poste

Actalent is seeking an experienced Electrical/Electromechanical Engineer to support development, testing, troubleshooting, and ongoing improvement of medical devices in a regulated manufacturing environment. This role focuses on sustaining engineering, design modifications, and problem-solving within FDA-regulated contexts.

The candidate should have a strong electrical engineering foundation, hands-on experience with complex electromechanical systems, and familiarity with ISO/IEC medical device