Medical Device Engineer

Medical Device Engineer

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

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.
• Support regulatory submissions.
• Mentor junior electrical engineers.

Essential Skills

• 10+ years of experience in electrical engineering, specifically in medical device development.
• Expertise in root cause analysis and dealing with machine-related problems.
• Comprehensive understanding of systems engineering, quality assurance, and electrical design.
• Experience in printed circuit board design and analysis, with proficiency in Altium Designer or similar software.
• Understanding of process validation and statistical analysis.
• Familiarity with FDA Design Controls and EU Medical Device Directive requirements.
• Experience with electro-mechanical manufacturing, depot service, and field service processes and operations.

Additional Skills & Qualifications

• Bachelor's Degree in Electrical Engineering.
• Experience with system-level requirements definition.

Work Environment

The position offers a hybrid work environment, with 3 days per week onsite in the Racine, Wisconsin area, and 2 days working remotely. The role includes collaboration with cross-functional teams and requires adherence to a professional dress code while onsite. The company offers an annual bonus of up to 15%.

Pay and Benefits

The pay range for this position is $60.00 - $80.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• 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)

Workplace Type

This is a hybrid position in Kenosha,WI.

Application Deadline

This position is anticipated to close on Oct 31, 2025.