JOB ID: 190002J6
Responsibilities may include the following and other duties may be assigned.
- Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
- Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
- Completes risk analysis studies of new design and processes.
- Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
- Ensures that corrective measures meet acceptable reliability standards.
- Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
- May develop mathematical models to identify units, batches or processes posing excessive failure risks.
- As necessary, proposes changes in design or formulation to improve system and/or process reliability.
- May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
- May maintain Twelve Quality System documentation and records.
- May provide quality support to manufacturing operations, quality initiatives, and support production quality issues resolution.
- May support customer complaint analysis and complaint trending.
- May support Product Impact Assessments.
- May support Twelve Facilities activities (Clean room, EHS).
- May support receiving inspection activities
- May support component engineering and/or supplier quality
- Mentor other engineers and technicians on the application of quality tools.
Must Have: Minimum Requirements
To be considered for this position, please ensure the minimum requirements are evident on your resume.
- Bachelor’s Degree in Engineering or Science field with 4 + years of experience in Quality and/or Engineering OR Advanced Degree in Engineering or Science field with 2+ years of experience in Engineering and/or Quality
Nice to Have
- 2+ years’ experience in product & process development
- 2+ years’ experience in the Medical Device or highly regulated industry strongly preferred
- MS in Engineering, Bioengineering, or Biotechnology is a plus
- ASQ Certified Quality Engineer or Six Sigma Black Belt is a plus
- Internationally certified quality auditor designation is a plus
- Project Management Professional (PMP) certification is a plus
- 3 years’ experience in product & process development
Bachelor's Degree in Engineering or Science field w/ 4 years experience in quality or engineering OR advanced degree in those fields w/ 2 years experience