Risk Management 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.

As a Risk Management Quality Engineer, you will play a critical role in ensuring the safety, quality, and regulatory compliance of Heartstream's products throughout their lifecycle. You will develop and maintain product risk management and safety documentation, assess product designs and post-market performance data, and partner with cross-functional teams to identify hazards, evaluate risks, and implement effective risk controls.

This role combines technical problem-solving, regulatory expertise, and data-driven decision-making to help ensure our products meet the highest standards of safety, quality, and compliance. You will also leverage approved AI and analytical tools to improve efficiency while maintaining the rigorous oversight required within a regulated medical device environment.

• Apply risk assessment methodologies, including Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA), in accordance with ISO 14971 to identify hazards, evaluate risks, and establish appropriate risk controls.
• Develop, maintain, and update product risk management files and safety documentation, ensuring accuracy, completeness, and compliance with regulatory requirements and company procedures.
• Assess product safety and compliance through analysis of design, verification, validation, manufacturing, and post-market surveillance data.
• Conduct root cause investigations and support corrective and preventive actions (CAPA) to address product safety and quality concerns.
• Monitor and evaluate post-market performance data to identify emerging trends, risks, and opportunities for product improvement.
• Prepare safety reports and communicate findings, recommendations, and risk mitigation strategies to stakeholders, including leadership and regulatory bodies.
• Partner with engineering, quality, regulatory, and manufacturing teams to ensure product safety requirements are appropriately integrated throughout the product lifecycle.
• Support internal teams by providing guidance and training on product safety principles, risk management practices, and compliance requirements.
• Contribute to the continuous improvement of safety, compliance, and quality processes to improve efficiency and effectiveness.
• Stay current with evolving regulatory requirements, industry standards, and best practices, incorporating new knowledge into product safety programs.
• Utilize approved AI tools and validated analysis tools to streamline workflows, develop analytical solutions, and accelerate data review while maintaining appropriate human oversight.
• Execute and support validation activities for software tools and spreadsheets used to support quality-related decisions, ensuring objective evidence is documented and maintained.
• Support the development and execution of validation plans, protocols, reports, and related documentation.

• 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.
• This role can either be hybrid from our Bothell, WA office or remote within the United States.

• You have a Bachelor's degree in Mechanical Engineering, Electronics Engineering, Science, Quality Engineering, or a related discipline.
• You have no prior experience required with a Bachelor's degree, or a minimum of 2 years of experience in Quality Engineering, Safety Engineering, Process Engineering, or a related field with vocational education.
• You have experience applying risk management principles and methodologies, including FMEA, FTA, and ISO 14971.
• You have knowledge of medical device quality systems and regulatory requirements, including ISO 13485 and FDA…