Engineer I, Product Analysis

About the Role

We are seeking an Engineer I, Product Analysis to join our team. In this role, you will perform technical failure analysis on explanted biomedical implant products within a laboratory setting. You will utilize analytical techniques and theoretical engineering principles to develop investigative protocols, identify root-cause failure mechanisms, and perform component-level and circuit analysis.

Responsibilities

• Failure Analysis: Perform failure analysis on explanted long-term biomedical implant products. Apply engineering principles and analytical techniques to identify root-cause failure mechanisms.
• Cross-Functional Collaboration: Partner effectively with Product Development, Engineering, Manufacturing, and Product Surveillance teams to solve complex problems and share findings.
• Quality & QMS Support: Proactively identify quality improvements related to failure analysis. Support initiatives in alignment with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory guidelines.
• Regulatory Compliance: Comply with U.S. Food and Drug Administration (FDA) regulations, medical device reporting standards, and company operating procedures.
• Lab Support & Mentorship: Aid in defining test equipment requirements to meet quality objectives. May assist, guide, or mentor less experienced laboratory staff on complex investigations.
• Project Management: Manage multiple ongoing tasks and investigations simultaneously, ensuring all project deadlines are met in a fast-paced environment.

Qualifications & Requirements

• Education: Bachelor's Degree in Engineering is required (Electrical or Biomedical Engineering is preferred).
• Experience: Prior engineering work experience is preferred, ideally within a laboratory or medical device environment.
• Regulatory Knowledge: Familiarity with global regulations for medical device reporting and medical terminology is highly advantageous.

Skills

• Strong written and oral communication skills.
• Exceptional organizational skills, attention to detail, and robust follow-up capabilities.
• Proven ability to work independently as well as collaboratively within a diverse, cross-functional team.
• Demonstrated capability to multitask, prioritize effectively, and meet tight deadlines.