Duration
6-12 mos
Job Description
Role: Our client is looking for a Failure Analysis Complaints investigator (minimum 5 years’ experience) to help with the analysis of their devices. This individual will be joining the Post-Market Surveillance group assisting in complaint handling, writing investigations, and working cross functionally with groups within the organization to report findings to assist in the development of process and product improvements. They will play a meaningful role in the development and implementation of continuous improvement efforts within the organization.
Utilize failure analysis lab equipment such as: optical digital microscopes, probes, X-ray systems, custom electrical test software, data log applications, and other test equipment and fixtures.
Skills
- FMEA, complaints/investigations, root cause analysis, Medical Device, ISO 13485/ 14971
- Plus: ASQ CQE, Six Sigma, or similar certifications
- Would like to see some sort of Engineering or Software or Computer Science Degree
- The Staff Failure Analysis Engineer will be responsible for the hands-on technical analysis of sophisticated devices, components, hardware, and software to determine the root cause of failures or device issues. This is an individual contributor role for an inquisitive and driven team player who will become intimately familiar with our medical devices and report out on findings to assist in the development of process and product improvements. The Staff Failure Analysis Engineer plays a meaningful role in the development and implementation of continuous improvement efforts within the organization.
Responsibilities
- Collaborate with Engineers, Suppliers, Clinical Specialists, Field Service Engineers and Manufacturing personnel to facilitate a deep understanding of device functionality and failures and to perform in depth root cause analysis.
- Design and execute experiments and test methods to test theories to refine failure modes and determine root cause.
- Acquire, analyze, and interpret information from data logs and various applications as well as perform physical (hands-on) deconstruction of devices as part of root cause analysis.
- Utilize failure analysis laboratory equipment, such as: optical digital microscopes, probes, X-ray systems, custom electrical test software, data log applications, and other test equipment and fixtures in support of failure analysis.
- Write formal analysis reports, resulting in clear and accurate messaging about analysis findings for a broad audience.
- Provide frequent verbal and written updates of work-in-progress for various meetings.
- Enhance investigation methodologies, develop and validate new test fixtures, and mentor the analysis team in the execution of those methods and tools.
- Own CAPAs and drive product and process improvements.
Required
- Bachelor of Science degree in Mechanical Engineering, Electrical Engineering, Computer Science or related field
- Prior experience in a failure analysis role
- 6 years of proven experience in a regulated environment (medical device, aerospace/defense, or similarly regulated industry)
- Experience using failure analysis laboratory equipment, such as: optical digital microscopes, probes, X-ray systems, custom electrical test software, data log applications, and other test equipment and fixtures in support of failure analysis.
- Experience working with ISO 13485 and 14971, GMP guidelines, FDA regulations
- Sophisticated analytical and problem-solving skills
- Confirmed ability to articulate risk and make critical decisions regarding product quality and quality system compliance
- Proficiency in root cause analysis tools and techniques (e.g. Hazard Analysis, FMEA, Fault Tree, Pareto diagrams, cause-and-effect diagrams, 5 whys, etc.)
- Tenacious attention to detail and consistency in work quality
- Proven understanding and ability in the use of statistical methods including trend analysis, Pareto, and other basic charting techniques
- Outstanding communication, presentation and interpersonal skills working within all levels of the organization
- An approachable individual who provides a high level of teamwork and multi-functional collaboration
- Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative demeanor
Onsite: Failure Analysis Complaints Investigations Consultant – 1 Spot (234623)
