Remote Risk & Quality Engineer – Medical Devices

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 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.