Senior Quality Engineer

<div class="content-intro"><p>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.</p></div><p><strong>Job Overview:</strong></p> <p><em>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 </em><em>compliance activities.</em></p> <p>&nbsp;</p> <p><strong>Roles &amp; Responsibilities | What you'll do:</strong></p> <h4>1. Drive Design Assurance in Product Development</h4> <ul> <li>Ensure compliance with design control requirements (ISO 13485, FDA 21 CFR Part 820, EU MDR, and Health Canada regulations) throughout the product lifecycle.</li> <li>Partner with R&amp;D and cross-functional teams to implement risk-based approaches to product design.</li> <li>Develop and maintain Design History Files (DHF) to support regulatory submissions and audits.</li> </ul> <h4>2. Conduct Risk Management Activities</h4> <ul> <li>Lead Failure Modes and Effects Analysis (FMEA) for design, process, and usability risks.</li> <li>Ensure compliance with ISO 14971 risk management requirements.</li> <li>Facilitate risk assessments and collaborate with cross-functional teams to mitigate potential hazards.</li> </ul> <h4>3. Develop and Execute Verification &amp; Validation (V&amp;V) Plans</h4> <ul> <li>Define test strategies, acceptance criteria, and protocols for design verification and validation.</li> <li>Review and approve test reports and data analysis to ensure compliance with regulatory standards.</li> <li>Maintain traceability from user needs to design inputs, outputs, and validation results.</li> </ul> <h4>4. Ensure Compliance with Regulatory &amp; Quality Standards</h4> <ul> <li>Support internal and external audits related to design assurance and regulatory compliance.</li> <li>Ensure documentation aligns with FDA QMSR, EU MDR, ISO 13485, IEC 62304 (Software),&nbsp; 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 &amp; RoHS.</li> </ul> <h4>5. Support Design Transfer &amp; Manufacturing Readiness</h4> <ul> <li>Collaborate with manufacturing and suppliers to ensure design for manufacturability (DFM) and process validation.</li> <li>Define quality control plans and inspection criteria for new products.</li> <li>Conduct supplier quality assessments and ensure compliance with component specifications.</li> </ul> <h4>6. Drive Continuous Improvement in Quality Systems</h4> <ul> <li>Identify opportunities to enhance design control processes and documentation.</li> <li>Develop and refine standard operating procedures (SOPs) for design assurance activities.&nbsp;</li> </ul> <p>&nbsp;</p> <p><strong>Experience | What you'll bring:</strong></p> <ul> <li>Education: Bachelor’s degree in Engineering, Biomedical Engineering, or a related field.</li> <li>Experience: Minimum 10 years in medical device quality engineering with a focus on design assurance.</li> <li>Regulatory Knowledge: Strong understanding of ISO 13485, FDA 21 CFR Part 820 &amp; Part 11, EU MDR, ISO 14971 (Risk Management), ISO 10993-1 Biocompatibility, FDA/EU/UK Food Safe Regulations, WERCSmart, RoHS compliance.</li> <li>Technical Skills: Experience with risk management tools (FMEA, Hazard Analysis), design verification/validation, and statistical methods.</li> <li>Software Skills: Proficiency in MS Office, Quality Management Systems (QMS), and statistical tools (Minitab, Tableau).</li> <li>Soft Skills: Strong analytical, problem-solving, and cross-functional collaboration skills.</li> <li>Physical abilities:</li> <ul> <li>Ability to work in an office setting, collaborating with R&amp;D and manufacturing teams.</li> </ul> </ul> <p>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.</p><div class="content-conclusion"><p><span style="color: #222222; font-size: 15px;">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.&nbsp;</span></p></div>