Willow Innovations, Inc.

Willow Innovations, Inc.

Senior Quality Engineer

Mountain View, CA · Senior

Sponsorship not specified$180k-$200kDetected 80 days ago
Data AnalysisData VisualizationProduct ManagementFDA RegulatoryMedical DevicesCollaborationProblem SolvingMicrosoft Office

About the role

  • The Senior Quality Engineer will participate in the implementation and maintenance of

Responsibilities

  • Drive Design Assurance in Product Development
  • Partner with R&D and cross-functional teams to implement risk-based approaches to product design.
  • Develop and maintain Design History Files (DHF) to support regulatory submissions and audits.
  • Lead Failure Modes and Effects Analysis (FMEA) for design, process, and usability risks.
  • Facilitate risk assessments and collaborate with cross-functional teams to mitigate potential hazards.
  • Develop and Execute Verification & Validation (V&V) Plans
  • Define test strategies, acceptance criteria, and protocols for design verification and validation.
  • Maintain traceability from user needs to design inputs, outputs, and validation results.
  • Support internal and external audits related to design assurance and regulatory compliance.
  • Support Design Transfer & Manufacturing Readiness

Requirements

  • Bachelor's degree in Engineering, Biomedical Engineering, or a related field.

Skills

  • Proficiency in MS Office, Quality Management Systems (QMS), and statistical tools (Minitab, Tableau).
  • Strong analytical, problem-solving, and cross-functional collaboration skills.
  • Software
  • Soft
  • Physical abilities:
  • Ability to work in an office setting, collaborating with R&D and manufacturing teams.
  • The salary range for this position is $180,000-$200,000/year depending on experience.
  • Willow is proud to be an equal opportunity workplace.

Compensation

  • The salary range for this position is $180,000-$200,000/year depending on experience.

Benefits

  • Willow is a platform for products that help improve the lives and health of women.
  • Ensure compliance with design control requirements (ISO 13485, FDA 21 CFR Part 820, EU MDR, and Health Canada regulations) throughout the product lifecycle.

Company info

  • We are a mission-driven team of experienced inventors, mothers, and fathers dedicated to making a difference in women's lives.
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