# Senior Quality Engineer at Willow

- Company: Willow
- What the company does: About Willow Buildings are more complex than ever — and the teams responsible for running them are still working with fragmented tools, disconnected data, and reactive workflows. Willow is changing that. Backed by NEA.
- Company website: https://onewillow.com/
- Type: Startups
- Level: Senior
- Location: Mountain View, CA
- Work setup: On-site
- Pay: $180K to $200K base salary per year (USD)
- Posted: 2026-02-23
- Apply by: 2026-10-08
- Apply: https://job-boards.greenhouse.io/willowinnovations/jobs/5808904004
- Page: https://www.1752.vc/careers/jobs/willow-senior-quality-engineer/

## About the role

The Senior Quality Engineer will participate in the implementation and maintenance of QSR (21 CFR 820) and ISO 13485: 2016 quality systems and qualification activities of Willow Innovations medical breast pump products and non-medical consumer products in support of the Company’s development, manufacturing, quality, regulatory, and clinical affairs efforts.

## What they're looking for

- Education: Bachelor’s degree in Engineering, Biomedical Engineering, or a related field
- Experience: Minimum 10 years in medical device quality engineering with a focus on design assurance
- Regulatory Knowledge: Strong understanding of ISO 13485, FDA 21 CFR Part 820 & Part 11, EU MDR, ISO 14971 (Risk Management), ISO 10993-1 Biocompatibility, FDA/EU/UK Food Safe Regulations, WERCSmart, RoHS compliance
- Technical Skills: Experience with risk management tools (FMEA, Hazard Analysis), design verification/validation, and statistical methods
- Software Skills: Proficiency in MS Office, Quality Management Systems (QMS), and statistical tools (Minitab, Tableau)
- Soft Skills: Strong analytical, problem-solving, and cross-functional collaboration skills

Tags: Clinical Regulatory Quality (CRQ)