Engineer, Biomedical Engineer

Engineer I, Product Analysis (Electronics Lab)

Location:Burlington, MA
Onsite:100% onsite
Pay:$44–$47/hr

The Engineer I, Product Analysis supports the Product Analysis Laboratory by performing failure analysis on explanted biomedical implant products. This role applies electrical and biomedical engineering principles to identify root cause failure mechanisms at the device and component level, working cross-functionally with engineering, manufacturing, and quality teams in a regulated medical device environment.

• Perform device- and component-level failure analysis on explanted long-term biomedical implant products
• Develop and execute investigative and test protocols to determine root cause failure mechanisms
• Conduct circuit analysis and electronics troubleshooting
• Apply analytical and creative problem-solving techniques to complex technical investigations
• Support continuous quality and process improvement initiatives related to failure analysis
• Collaborate cross-functionally with Product Development, Engineering, Manufacturing, and Product Surveillance
• Assist in defining and selecting test equipment to support quality investigations
• Ensure compliance with FDA regulations, QMS/EMS requirements, and internal procedures
• Mentor and support less experienced lab personnel as needed
• Manage multiple investigations simultaneously while meeting deadlines

Required

• Bachelor’s degree in Engineering
• Strong written and verbal communication skills
• Ability to work independently and in cross-functional teams
• Strong organization, prioritization, and attention to detail

Preferred

• Electrical Engineering or Biomedical Engineering degree
• Experience in engineering, electronics labs, or failure analysis
• Knowledge of medical device regulations, medical terminology, or MDR reporting