Senior Quality Engineer: Medical Device Design Assurance

Willow Innovations, Inc.; Mountain View (CA); Hybrid; USD 180,000 - 200,000; Full time

Job summary

Willow Innovations, Inc. in Mountain View, CA seeks a Senior Quality Engineer to drive design assurance and ensure regulatory compliance across product development, design control, and supplier activities.

The role leads FMEA, DHF maintenance, V&V planning, and audits, collaborating with R&D and manufacturing. Hybrid work, competitive compensation, and growth opportunities are offered in a mission-driven environment.

Qualifications

• 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 regulatory knowledge of ISO 13485, FDA 21 CFR Part 820 & Part 11, EU MDR, ISO 14971, ISO 10993-1.
• Technical skills in risk management (FMEA, Hazard Analysis), design verification/validation, and statistical methods.
• Software skills in MS Office, QMS software, and statistical tools (Minitab, Tableau).
• Soft skills: analytical, problem-solving, cross-functional collaboration.
• Physical ability to work in an office setting with R&D and manufacturing teams.

Responsibilities

• Drive Design Assurance in Product Development
• Ensure compliance with design control requirements (ISO 13485, FDA 21 CFR Part 820, EU MDR, and Health Canada)
• 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
• Conduct Risk Management Activities (FMEA, risk analyses)
• Lead FMEA for design, process, and usability risks
• Ensure compliance with ISO 14971 risk management requirements
• Facilitate risk assessments with cross-functional teams to mitigate hazards
• Develop and execute Verification & Validation (V&V) plans
• Define test strategies, acceptance criteria, and protocols for design V&V
• Review and approve test reports and data analysis
• Maintain traceability from user needs to design inputs/outputs/validation
• Support internal and external audits related to design assurance and regulatory compliance
• Define quality control plans and inspection criteria for new products
• Conduct supplier quality assessments and ensure component specifications
• Drive continuous improvement in quality systems
• Develop and refine SOPs for design assurance activities

Skills

Quality engineering

Design assurance

Regulatory knowledge

Risk management (FMEA)

Statistical methods

Cross-functional collaboration

Data analysis

Problem solving

Education

Bachelor’s degree in Engineering

Tools

Minitab

Tableau

QMS software

Job description

Willow Innovations, Inc. in Mountain View, CA seeks a Senior Quality Engineer to drive design assurance and ensure regulatory compliance across product development, design control, and supplier activities.

The role leads FMEA, DHF maintenance, V&V planning, and audits, collaborating with R&D and manufacturing. Hybrid work, competitive compensation, and growth opportunities are offered in a mission-driven environment.