Quality Engineer
Medical Devices
Posted on 2/2/2022

201-500 employees

Modern healthcare platform
Company Overview
Forward is on a mission is to create a world where everyone has access to the best medical care available
San Francisco, CA, USA
Experience Level
  • Extremely comfortable solving difficult & complex problems from first principles, overcoming ambiguity, willing to assume many roles (even the less glorious ones), & working with a team (assertively, yet kindly & humbly)
  • Minimum of five (5) years relevant work experience in quality assurance, failure analysis or product development
  • Knowledge of ISO 9001:2015, ISO13485:2016, and 21 CFR Part 820 quality systems is required
  • Six Sigma experience
  • In-depth understanding of statistical techniques such as normality analysis, confidence intervals and should be able to analyze and interpret data with high confidence
  • Able to manage multiple complex projects simultaneously
  • Excellent oral and written communication skills, backing up rationale with analysis
  • Experience working at a high-performing hardware-focused startup and/or top-tier device manufacturer shipping multiple complex high-quality low & medium volume products
  • Dedicated to the audacious & long-term mission of providing the best healthcare to everyone in the world
  • Sample size estimation and justification for design verification and product validation
  • Test plan creation
  • Test tooling specification
  • Gauge R&R on any test tooling, as needed
  • Test execution and analysis
  • Consult on fleet quality management approaches
  • Develop quality engineering methodologies to support manufacturing changes and/or retrofit procedure and verification
  • Supplier audit and basic project management to support builds as well as online testing
  • Serve as a cross-functional technical lead in statistical analysis techniques, experimental design, data analysis, sampling techniques and other traditional QA Engineering areas of expertise
  • Create statistical plans to validate intermediate outputs
  • Contribute to hardware scalability improvements
  • Support documentation efforts for regulatory submissions
  • Your work will directly contribute to improving and saving lives. For real