Senior Quality Engineer

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.

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.

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.

Identify opportunities to enhance design control processes and documentation.

Develop and refine standard operating procedures (SOPs) for design assurance activities.

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.