Failure Investigation Engineer
A molecular diagnostics manufacturing company is seeking a Failure Investigation Engineer to join their team!
The Failure Investigation Engineer joins a team of 4-8 individuals focused on diagnosing and resolving technical issues and providing technical recommendations. Issues may arise from both internal and external customers, including, but not limited to, production, customer complaints, and development. Teams typically focus on medium and high complexity issues for resolution requiring a quick turnaround time. The teams also provide key feedback to development organizations on guidelines for quality and reliability expectations.
ESSENTIAL JOB RESPONSIBILITIES:
- Lead discussion on failure mode and risk analysis
- Determine impact of failures to different areas of the business
- Lead discussion on qualification plans based off risk analysis of changes to final product
- Advise on implementation strategy for BOM’s
- Recommend and implement improvements to current work flows, procedures and techniques Provide recommendations for investigation direction and/or countermeasures
- Continuously document progress during investigations and prepare final reports
- Analyze data to identify trends and areas for investigation
- Investigate failures through established root cause analysis techniques and methods, such as data analysis and physical inspection
- Design, execute, and interpret single and double factor experiments
Bachelor’s degree or higher in biological or engineering related discipline
2 or more years of relevant professional experience
Understanding of PCR and Cepheid products
Learn through on-the-job training
Statistics experience, including power levels, t-test, variance, and sampling plans
Ability to work independently and cross-functionally
Excellent organizational and communication skills (oral and written)
Excellent writing and documentation skills
Experience working in a laboratory
Physical requirements/abilities: Pipetting, Sitting or standing at a lab bench, Operation of machinery, Occasional lifting
Other: This role requires the associate is hands-on in the laboratory, including the use of hazardous chemicals and clinical specimens.
Experience with PFMEA
Experience with Risk Analysis
Experience with part and automation qualifications
Experience with BOM’s
Experience with design of experiments (DoE)
Experience with root cause analysis techniques and documentation of results
Experience working in a biology lab environment with clinical specimens
Experience working in a manufacturing environment and/or within manufacturing operations under cGMP, ISO and FDA regulations
Experience working with and running Cepheid products
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.