---
title: 'Senior Quality Engineer at Willow Innovations'
canonical: 'https://feeny.ai/job/senior-quality-engineer-willow-innovations-mountain-view-w5g71rwxar70'
type: 'job'
last_seen: '2026-09-10'
---

# Senior Quality Engineer at Willow Innovations

- **Company:** Willow Innovations
- **Location:** Mountain View, CA
- **Posted:** 2026-02-23
- **Last confirmed live:** 2026-09-10
- **Apply:** https://job-boards.greenhouse.io/willowinnovations/jobs/5808904004

## Job description

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.

Roles & Responsibilities | What you'll do:

1. Drive Design Assurance in Product Development

- 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 maintain Design History Files (DHF) to support regulatory submissions and audits.

1. Conduct Risk Management Activities

- Lead Failure Modes and Effects Analysis (FMEA) for design, process, and usability risks.
- Ensure compliance with ISO 14971 risk management requirements.
- Facilitate risk assessments and collaborate with cross-functional teams to mitigate potential hazards.

1. Develop and Execute Verification & Validation (V&V) Plans

- Define test strategies, acceptance criteria, and protocols for design verification and validation.
- Review and approve test reports and data analysis to ensure compliance with regulatory standards.
- Maintain traceability from user needs to design inputs, outputs, and validation results.

1. Ensure Compliance with Regulatory & Quality Standards

- Support internal and external audits related to design assurance and regulatory compliance.
- Ensure documentation aligns with FDA QMSR, EU MDR, ISO 13485, IEC 62304 (Software),  IEC 60601 (Safety), IEC 62366 (Usability),Health Canada MDR (SOR/98-282), and ISO 10993-1 Biocompatibility, FDA/EU/UK Food Safe Regulations, UL WERCSmart, REACH & RoHS.

1. Support Design Transfer & Manufacturing Readiness

- Collaborate with manufacturing and suppliers to ensure design for manufacturability (DFM) and process validation.
- Define quality control plans and inspection criteria for new products.
- Conduct supplier quality assessments and ensure compliance with component specifications.

1. Drive Continuous Improvement in Quality Systems

- Identify opportunities to enhance design control processes and documentation.
- Develop and refine standard operating procedures (SOPs) for design assurance activities.

Experience | What you'll bring:

- 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.
- Physical abilities:
- 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. This is a hybrid role based in Mountain View, CA. The salary range for this position is $180,000-$200,000/year depending on experience. Willow is proud to be an equal opportunity workplace. We are committed to equal employment opportunities regardless of gender, race, religion, sexual orientation, gender identity, age, marital status, disability, or Veteran status.

## About Willow Innovations

## Company Overview
- **One-liner**: Willow Innovations designs and manufactures wearable, app-connected breast pumps and maternal health solutions to give mothers freedom and mobility.
- **Entity Type**: Private
- **Headquarters**: Mountain View, California, USA
- **Founded**: 2014
- **Founders**: Not publicly available (the company was built by a team of women innovators)

## Core Business
- Primary industry/industries: FemTech (Female Technology), Maternal Health, Consumer Medical Devices
- Target customers: B2C (new mothers and breastfeeding parents), B2B (healthcare providers, hospitals)
- Mission statement: “Bring joy to motherhood” and “Build solutions to mom’s most meaningful problems.”

## Products & Services
- **Willow Wearable Breast Pump**: The first all-in-one, in-bra wearable breast pump (launched 2017). FDA approved, clinically tested, 100% leak-proof, and app-connected. Selected as one of TIME’s 25 Best Inventions.
- **Willow 3.0**: The latest generation pump, featuring smart technology for personalized pumping, improved fit, and higher milk output.
- **Willow Accessories & Breast Care**: A range of accessories and breast care products designed to support the full pumping journey.
- **Willow App**: Companion app with smart controls, milk volume tracking, and in-app resources including access to International Board Certified Lactation Consultants and Willow Mom Coaches.
- **Elvie x Willow Platform**: Following a 2025 partnership/merger with Elvie, the combined entity is building a broader maternal care platform offering solutions in feeding and postpartum wellness.

## Market Standing
- **Valuation**: Not publicly disclosed (private company)
- **Key Metric**: Total employee count of approximately 90 as of latest reports
- **Notable Investors/Partners**: Not publicly disclosed in available sources; the company is noted as the only leading pump brand founded and based in the U.S. with a team built of women.
- **Growth Signals**: 
  - 120+ patents and 5 trademarks held
  - Merged with Elvie in 2025 to form a combined maternal care platform, signaling significant scale and market consolidation
  - Expanding from hardware into a full platform (app, coaching, community)
  - Actively hiring for roles including Senior Quality Engineer, Sr. Global Demand Planning Manager, Amazon Marketplace Manager, and Senior Software Engineer

## Competitive Advantages
- **First-Mover & IP Moat**: Invented the first wearable breast pump in 2017, with a strong patent portfolio (120+ patents).
- **Brand Trust & Clinical Validation**: FDA approved, clinically tested, and US-based manufacturing. Selected as one of TIME’s 25 Best Inventions.
- **Leak-Proof Technology**: The only 100% leak-proof wearable pump on the market, a critical differentiator for user experience.
- **FemTech Leadership**: As a pioneer in female-first technology, the company has deep understanding of women’s health needs, now amplified by the Elvie partnership.
- **Community & Support**: Offers in-app lactation consultants and Mom Coaches, creating a sticky ecosystem beyond just the hardware.

## Strategic Focus
- **Platform Expansion**: Moving from a single product (wearable pump) to a comprehensive maternal care platform (Elvie x Willow) covering feeding and postpartum wellness.
- **Global Reach**: Scaling through the Elvie partnership to reach a broader international audience.
- **Technology & AI Integration**: Leveraging “world-class smart technology” and exploring AI (e.g., “Ema AI for women’s health”) to enhance the user experience.
- **Product Innovation**: Continuing to develop new solutions for real-life problems, including accessories and breast care, not just pumps.

## Why Work Here
- **Mission-Driven Culture**: Strong focus on supporting mothers and bringing joy to motherhood. The company states, “Because when you’re taking care of the baby, who takes care of you? We do.”
- **Flexibility & Work-Life Balance**: 
  - Hybrid workspace (combination of remote and on-site work)
  - Flexible work schedules with work-from-home opportunities
  - “No Meeting Wednesdays” for uninterrupted focus time
  - Generous and flexible time off
- **Parental Leave**: New parents receive 16 weeks paid parental leave, plus six 4-day weeks to smoothly transition back to work.
- **Health & Wellness**: Comprehensive benefits including medical, dental, vision, wellness programs, health & gender affirmation reimbursement, 401k, life insurance, and disability options.
- **Diversity & Inclusion**: Strong commitment to building a diverse and inclusive workforce, with a stated mission to support all mothers on their unique motherhood journey.
- **Engineering & Innovation**: Opportunity to work on award-winning, patented technology that has a direct impact on users’ lives. Roles available in software engineering, quality engineering, and commercial operations.
- **Office Locations**: HQ in Mountain View, CA with remote/hybrid options available for some roles.

## Sources
1. [onewillow.com - About Page](https://onewillow.com/pages/about)
2. [onewillow.com - Homepage](https://onewillow.com/)
3. [onewillow.com - Careers Page](https://onewillow.com/pages/careers-legacy)
4. [Built In - Willow Innovations Profile](http://www.builtin.com/company/willow-innovations-inc)
5. [Greenhouse - Willow Innovations Job Board](http://job-boards.greenhouse.io/willowinnovations)

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