Senior Quality Engineer

Willow Innovations•Mountain View, CA

19h•Hybrid

About The Position

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. Job Overview: 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.

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, or a related field.
Minimum 10 years in medical device quality engineering with a focus on design assurance.
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.
Experience with risk management tools (FMEA, Hazard Analysis), design verification/validation, and statistical methods.
Proficiency in MS Office, Quality Management Systems (QMS), and statistical tools (Minitab, Tableau).
Strong analytical, problem-solving, and cross-functional collaboration skills.
Ability to work in an office setting, collaborating with R&D and manufacturing teams.
Occasional travel may be required for supplier audits, manufacturing support, or regulatory interactions.