Risk Management Quality Engineer

Heartstream; Bothell (WA); Hybrid; USD 70,000 - 90,000; Full time

Benefits offered by this job

401(k) match

HSA with company contribution

Employee stock purchase plan

Education reimbursement

Generous PTO

Job summary

Heartstream is seeking a Risk Management Quality Engineer to ensure safety, quality, and regulatory compliance of our medical devices throughout their lifecycle. You will develop risk management files, assess designs and post-market data, and collaborate with engineering, quality, regulatory, and manufacturing teams.

The role requires applying FMEA/FTA per ISO 14971, maintaining documentation, supporting CAPAs, and leveraging AI tools for data review while preserving required human oversight.

Qualifications

• Ability to apply risk management principles (FMEA, FTA) and ISO 14971.
• Knowledge of medical device quality systems (ISO 13485, FDA) and GDP.

Responsibilities

• Apply risk assessment methodologies (FMEA/FTA) to identify hazards and establish risk controls.
• Develop and maintain product risk management files and safety documentation.
• Assess safety and compliance through design, verification/validation, manufacturing, and post-market data.
• Conduct root cause investigations and support CAPAs.
• Monitor post-market data to identify trends and improvements.

Skills

Risk assessment

Regulatory compliance

Analytical skills

Documentation

Cross-functional collaboration

Quality engineering

Education

Bachelor's degree in Mechanical/Electronics/Science/Quality Engineering or related

Job description

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 HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions.

Your Impact

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.

In this role, you will:

• 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.

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

You'll Thrive in this Role If:

• 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 regulations.
• You have experience investigating product quality or safety issues using structured root cause analysis methodologies.
• You possess strong analytical skills with the ability to interpret technical, quality, and post-market data to support informed decision-making.
• You are skilled in technical documentation and maintaining accurate records in a regulated environment.
• You have experience supporting software validation activities, validation protocols, and Good Documentation Practices (GDP).
• You are comfortable working with AI-assisted analysis tools while maintaining compliance with quality and regulatory requirements.
• You demonstrate strong communication and collaboration skills and can effectively work across multiple functions and stakeholders.
• You are proactive, detail-oriented, and committed to continuous improvement.

The pay range for this position is $70,000 to $90,000 annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge, skills, experience, business need, geographic location, and internal equity.

In addition, other compensation, such as an annual incentive bonus or long-term incentives, may be offered. Employees are eligible to participate in our comprehensive Heartstream Total Rewards benefits program, which includes generous PTO, 401(k) (up to 7% company match), HSA (with company contribution), employee 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.

Heartstream is an Equal Employment Opportunity Employer, including Disability/Veterans, and maintains a drug-free workplace.

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