Product Analysis Engineer
3 days ago
Product Analysis Engineer I
Job Summary:We are seeking a highly skilled Product Analysis Engineer I to join our team at Spectraforce Technologies. As a Product Analysis Engineer I, you will be responsible for performing failure analysis on explanted biomedical implant products and providing technical expertise to the Product Analysis Laboratory.
Main Responsibilities:- Perform failure analysis on explanted long-term biomedical implant products.
- Apply theoretical principles, evaluation, ingenuity, and creative/analytical techniques to identify root cause failure mechanisms.
- Meet deadlines on multiple assignments and operate in a diverse cross-functional team environment.
- Proactively find quality improvements related to Failure Analysis.
- Lead and assign work to less experienced personnel, and serve as a mentor when assisting less experienced lab staff in solving complex problems.
- Work cross-functionally and collaboratively with Product Development, Engineering, Manufacturing, and Product Surveillance.
- Aide in defining test equipment as required to accomplish quality responsibilities.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Bachelor's Degree in Engineering is Required.
- Electrical or Biomedical Engineering is preferred.
- Engineering work experience is preferred.
- Knowledge of global regulations for medical device reporting and medical terminology is a plus.
- Strong written and oral communication skills are required.
- Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
- Multitasking, prioritizing, and meeting deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
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