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.
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
More about this role
Willow is a platform for products that help improve the lives and health of women. We are a mission-driven team of experienced inventors, mothers, and fathers dedicated to making a difference in women’s lives. The Willow™ Wearable Breast Pump, selected as one of TIME's 25 Best Inventions in 2017 and 2018 CES Innovation Award for Wearable Technologies, is the first solution in our platform.
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. In addition, this position will support the development and implementation of quality systems, quality/reliability engineering disciplines, and compliance activities.
- Ensure compliance with design control requirements (ISO 13485, FDA 21 CFR Part 820, EU MDR, and Health Canada regulations) throughout the product lifecycle.
- Partner with R&D and cross-functional teams to implement risk-based approaches to product design.
- Develop and...
Browse similar: Startup jobs · San Francisco Bay Area