Senior Product Test Engineer
$97,000–$165,000 year
On-siteNorthridge, California, United States
Job Summary
Lead planning and execution of design verification and reliability test strategies for electromechanical medical device programs, from design planning through design transfer. Collaborate with cross-functional teams to characterize new hardware designs, novel delivery algorithms, and emerging technologies across electro-mechanical, electro-chemical, and software interfaces. Apply statistical techniques such as hypothesis testing, DOE, regression, and capability analysis to support test method validation, design characterization, root cause analysis, and verification and reliability demonstration activities. Review risk management deliverables including DFMEA/PFMEA and Hazard Analysis in collaboration with design quality, post-market quality, and medical safety functions, and develop test methodologies to address essential design outputs. Participate on project teams and technical review boards, lead change control evaluations, and coordinate quality decisions across engineering groups. Lead CAPA projects, support post-market analysis, and participate in internal and external regulatory audits.
Required Qualifications
- Bachelor's degree in engineering or science
- 4+ years of work experience in medical device development and/or development quality
- Master's Degree in Engineering or Science with 2+ years of work experience in medical device development and/or development quality
- On-site presence at our Northridge, CA facility is required the majority of the time
- Some flexibility for hybrid work
Desired Qualifications
- Bachelor's degree in Biomedical, Mechanical, Chemical, or Electrical Engineering
- Master's degree in Engineering, Quality, or Regulatory
- Experience working in an FDA-regulated or similarly regulated industry
- Working knowledge of 21 CFR 820, IEC 60601-1, IEC 60601-2-24, IEC 62304, ISO 13485, and ISO 14971
- Hands-on experience with design verification testing, test method development, and test method validation
- Understanding of the interdependencies of program work products and guide the teams in execution strategy and reviewing the program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports)
- Experience with DFMEA, Accelerated Life Testing, Reliability Growth, and Demonstration Testing
- Proficiency with statistical analysis tools such as MATLAB, Minitab, or Weibull++
- Experience with data acquisition software such as NI LabVIEW
- Experience with fixture design and 3D modeling tools such as SolidWorks
- Working knowledge of electromechanical devices, battery-powered devices, and/or electrochemical reactions
- Strong written and verbal communication skills with the ability to effectively communicate at multiple hierarchal levels in the organization
- Ability to multi-task, prioritize, meets/exceed deadlines and holds themselves, and others accountable
- Self-starter with strong organizational skills, ability to prioritize, and a sharp focus on quality and customer experience
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