Sr. Failure Analysis Quality Engineer
4045 Campbell Avenue, Menlo Park, CA 94025
Position Title: Sr. Failure Analysis Quality Engineer
Position Description: Protingent Staffing has an exciting direct hire opportunity with our client in Menlo Park, California.
- Function as the lead complaint investigator. Performing complaint investigations and working with cross functional teams as needed to determine root cause, ensuring all investigations are completed in timely manner.
- Perform complaint investigations including: analyzing returned products to understand failure mechanisms and root causes, assessing risk associated with the failures and determining need for corrective action
- Document failure analyses in complaint records
- Establish root cause failure analysis techniques, processes and test methods.
- Monitor incoming complaints and feedback, and analyze historical data to identify trends and areas for investigation and manage data for team review
- Participate in Product Surveillance Team to monitor and develop long-term improvements to our product and test their effectiveness.
- Present complaint data to management team
- Work with Customer Service to obtain and communicate information with a customer in response to issues associated with complaints
- Solid understanding of and experience in applying problem-solving tools including root cause analysis, statistical tools and processes, and design of experiments.
- Demonstrated experience evaluating, qualifying and managing failure analysis to ensure timely, complete and thorough analysis.
- Highly proficient in use of complex lab instruments and equipment (DVM, oscilloscope, micro-vu, microscopes, forge gauge testers, audiology equipment, etc.)
- Preferable to have computer programming and software applications knowledge.
- Working knowledge of GMP, Post Market Surveillance, Risk Management regulations and systems.
- Strong technical capability, verbal and written communication skills and effective interpersonal skills
- Ability to communicate with all levels of staff and present data to management when needed
- Ability to multitask, prioritize, handle multiple projects, meet aggressive deadlines, and work well under pressure
- Must be able to work independently and as part of a team
- Proficiency in MS Word, MS Excel, and MS PowerPoint required
- BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering or equivalent discipline
- Minimum of 2 years of experience in the medical device industry or equivalent combination of education and experience, performing failure investigations
- Minimum of 5 years of relevant professional experience
- Background in electronics. sustaining engineering and/or new product development engineering
- Working knowledge and understanding of FDA’ s QSRs, ISO 13485: 2003, MDD, and other national/international regulatory quality system requirements.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.