Quality Engineer

About the role

Lead design quality activities across the product lifecycle, ensuring new products are successfully transitioned into production while meeting quality and regulatory requirements.

Partner closely with R&D, Manufacturing, Regulatory Affairs, and Product Quality teams to drive product reliability, quality improvements, and compliance with global regulations.

Influence the development of innovative life-saving medical technologies by guiding design controls, validation strategies, risk management, and post-market quality activities.

Utilize post-market surveillance insights and field performance data to continuously improve product quality, safety, and reliability.

Build strong relationships across cross-functional teams, providing quality leadership, guidance, and mentorship to support successful product launches and sustained product excellence.

Develop deep expertise in systems-level quality engineering, design controls, process validation, risk management, and regulatory compliance within the medical device industry.

Impact

Your work will directly improve the quality of emergency medical services and enhance patient safety and survival rates by making high-quality care accessible to more people around the world. As part of a number one provider of therapeutic care solutions, your contribution will help us continue to save more lives every year.

Work Environment

For this office-based role, you will work in-person at least 3 days per week from our Bothell office.

Requirements

• 8–10+ years of experience in Quality Engineering, Design Quality, Product Quality, Safety Engineering, R&D Engineering, or a related discipline (or 5+ years with a Master's degree).
• Skills in Design Controls, Process Validation, Design Verification & Validation, Risk Management, CAPA, Root Cause Analysis, Reliability Engineering, Design for Quality (DFQ), Statistical Analysis, and Regulatory Compliance.
• Experience with Post Market Surveillance (PMS) and product reliability is highly desirable.
• Bachelor's or Master's Degree in Mechanical Engineering, Electronics Engineering, Science, or a related technical discipline. A Six Sigma Green Belt certification is preferred.
• Ability to successfully perform the minimum Physical, Cognitive, and Environmental job requirements of the role, with or without reasonable accommodation.
• Collaborative and influential professional with excellent communication and stakeholder management skills, capable of working effectively across multidisciplinary teams.
• Comfortable mentoring others, driving continuous improvement initiatives, and occasionally traveling as required to support business needs.

Benefits

• Generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• Stock purchase plan
• Education reimbursement

Pay

The pay range for this position is $100,000 to $145,000 annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation such as an annual incentive bonus, sales commission, or long-term incentives may be offered.