Engineering Manager, Hardware Testing for Medical Devices

What you'll do

• Manage a team of test engineers across design verification, automation, and system integration activities.
• Develop and implement test strategies for hardware, software, and integrated medical device components.
• Ensure on-time delivery of test milestones across multiple concurrent product development projects.
• Drive the development and adoption of automated test frameworks to improve efficiency and coverage.
• Create test plans and protocols that comply with regulatory standards like FDA, IEC 62304, and ISO 13485.
• Oversee system integration testing to ensure hardware and software function correctly as a unified system.
• Mentor, coach, and evaluate team members to foster technical growth and professional development.
• Collaborate with cross-functional teams including systems, software, hardware, and regulatory engineering.

What we're looking for

• Requires a Baccalaureate degree in Mechanical, Electrical, Computer, or Biomedical Engineering (or related engineering discipline).
• Requires 5 years of relevant experience for a Bachelor's degree or 3 years of relevant experience with an advanced degree.
• Experience developing or testing Software as a Medical Device (SaMD) or medical device software is preferred.
• Experience with test automation frameworks, specifically LabVIEW and TestComplete, is preferred.
• Hands-on experience with system integration testing of complex hardware/software systems is preferred.
• Familiarity with x-ray or medical imaging system testing is preferred.
• Working knowledge of IEC 60601-1 and IEC 60601-1-2 electrical safety and electromagnetic compatibility standards is preferred.
• Work authorization at the time of hire and for the duration of employment.