What are the responsibilities and job description for the Biomedical Electronics Engineer position at Stark Pharma?
Job Title: Biomedical Electronics Engineer
Location: Burlington, MA
Experience: 3 - 5 Years
Role Overview
The Engineer I Product Analysis will support failure analysis activities for long-term implantable biomedical devices within an electronics laboratory environment. This role focuses on hands-on investigation at both device and component levels, supporting root cause analysis efforts and contributing to product reliability and quality improvements. The position requires close collaboration with cross-functional engineering, quality, and regulatory teams.
Key Responsibilities
Location: Burlington, MA
Experience: 3 - 5 Years
Role Overview
The Engineer I Product Analysis will support failure analysis activities for long-term implantable biomedical devices within an electronics laboratory environment. This role focuses on hands-on investigation at both device and component levels, supporting root cause analysis efforts and contributing to product reliability and quality improvements. The position requires close collaboration with cross-functional engineering, quality, and regulatory teams.
Key Responsibilities
- Perform failure analysis on explanted implantable medical devices and associated electronic components
- Conduct device-level and component-level investigations using established analytical methods and tools
- Support root cause analysis by developing and executing investigative protocols
- Analyze electronic circuits to identify failure mechanisms and contributing factors
- Document findings clearly and accurately in technical reports and internal systems
- Collaborate with design, quality, manufacturing, and regulatory teams to support corrective actions
- Assist in trend analysis and data interpretation related to product performance and field returns
- Ensure all activities comply with applicable quality systems, regulatory standards, and internal procedures
- Bachelor's Degree in Engineering, preferably Electrical Engineering or Biomedical Engineering
- Fundamental knowledge of electronic circuit analysis and failure investigation techniques
- Understanding of root cause analysis methodologies
- Ability to follow structured investigation protocols and laboratory procedures
- Strong written and verbal communication skills
- Good organizational skills with the ability to manage multiple tasks simultaneously
- Exposure to medical device industry standards and regulatory requirements
- Familiarity with FDA regulations, Quality Management Systems, and medical device reporting
- Internship or academic project experience related to electronics, biomedical devices, or failure analysis
- Basic understanding of reliability engineering or product lifecycle analysis