Senior Design Assurance Engineer

$95,000 - $125,000 yearly
  • MedTronic
  • Santa Rosa, CA, USA
  • Mar 25, 2019
Full time Biotech Design Engineering Professional Services Science

Job Description

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



Matthew Stearns


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