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Sr. Failure Analysis Quality Engineer

Menlo Park, CA 94025

Posted: 02/06/2019 Employment Type: Direct Hire Industry: QA/Testing Job Number: 19432

Position Title:  Sr. Failure Analysis Quality Engineer

Position Description:  Protingent Staffing has an exciting direct hire opportunity with our client in Menlo Park, California.

Job Requirements:
  • 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

Job Qualifications:
  • 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.

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