Quality Engineer

Heartstream is building on our 40+ year legacy of growth and innovation in emergency medical technology to continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments. Heartstream includes leading brands and products like Heart Start AEDs, Intrepid and DFM
100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions.

Your Impact

• 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.

Our Commitment to Collaboration

• 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. With every project, you'll be making a world of difference.
• We believe collaboration is better together than apart. For this office-based teams this means working in-person at least 3 days per week from our Bothell office.

You'll thrive in the role if:

• You've acquired 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). This is an individual contributor role.
• Your skills include 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.
• You have a 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.
• You must be able to successfully perform the minimum Physical, Cognitive, and Environmental job requirements of the role, with or without reasonable accommodation.
• You're a collaborative and influential professional with excellent communication and stakeholder management skills, capable of working effectively across multidisciplinary teams. You are comfortable mentoring others, driving continuous improvement initiatives, and occasionally travelling as required to support business needs.

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. Employees are eligible to participate in our comprehensive Heartstreams Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

At Heartstream, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.