Biomedical Engineer

Biomedical Engineer

We are seeking a Biomedical Engineer to support failure investigations for implantable medical devices in a laboratory environment. This role focuses on identifying root cause failure mechanisms, conducting technical investigations, and improving overall product quality and reliability. The ideal candidate will work closely with cross functional engineering and quality teams while ensuring compliance with regulatory and quality requirements. This position requires strong analytical skills, attention to detail, and the ability to manage multiple investigations in a fast paced environment.

Key Responsibilities:

• Perform failure analysis on explanted implantable medical devices.
• Conduct root cause investigations using engineering principles and analytical techniques.
• Perform circuit analysis and device level component evaluations.
• Develop and execute investigation protocols to determine product failure mechanisms.
• Collaborate with Product Development, Manufacturing, Engineering, Quality, and Product Surveillance teams.
• Support continuous quality improvement initiatives related to failure analysis.
• Assist in defining laboratory test equipment required for investigations.
• Ensure compliance with Quality Management System requirements and regulatory standards.
• Document investigation findings and communicate technical results effectively.
• Manage multiple assignments while meeting project deadlines.
• Support mentoring of junior laboratory personnel when required.

Required Qualifications:

• Bachelor's Degree in Engineering is required.
• Electrical Engineering or Biomedical Engineering background is preferred.
• Knowledge or experience in Failure Analysis and Root Cause Analysis.
• Understanding of circuit analysis and device component level investigations.
• Strong analytical, organizational, and problem solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a laboratory environment.
• Comfortable working onsite in a laboratory environment while wearing required PPE/gowning

Preferred Qualifications:

• Engineering experience within the medical device industry.
• Knowledge of FDA regulations and medical device reporting requirements.
• Understanding of Quality Management Systems.
• Knowledge of medical terminology.
• Reliability engineering experience.
• Experience using engineering software, databases, spreadsheets, and word processing applications.

Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable.