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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
