Shape Medical Device Reliability. Drive Innovation. Enhance Patient Safety.
We're looking for a System Reliability Engineer specializing in medical devices to ensure the safety, reliability, and continuous performance of critical medical instruments and associated software. If you thrive on solving complex problems, driving innovation, and collaborating across teams, this role is for you.
What You'll Do : System Reliability
- Monitor, assess, and improve the reliability and safety of medical devices throughout their lifecycle.
- Ensure compliance with healthcare industry standards and regulations.
Failure Analysis
Perform root cause analysis for system failures or performance degradation.Document findings and implement corrective and preventive actions (CAPA) in collaboration with R&D, Manufacturing, Quality, and Field Services teams.Work with customer-facing groups to understand field issues and incorporate feedback into reliability designs.Reliability Testing
Develop and execute reliability test plans, including environmental, stress, and durability tests.Ensure medical instruments meet all necessary reliability and performance criteria.Risk Assessment and Mitigation
Conduct risk assessments (FMEA, FTA) for devices and systems.Identify potential risks to patient safety or device performance and collaborate with engineering teams to mitigate them.Product Lifecycle Support
Provide reliability engineering support during design, development, manufacturing, and post-market surveillance of medical devices.Collaborate with R&D to integrate reliability into product design.Installed Base Performance Monitoring
Track device performance in the field and define key performance indicators (KPIs).Implement monitoring tools for early detection of system anomalies.Automation & Tooling
Develop tools to automate monitoring, testing, and reporting of system reliability data.Ensure medical systems operate continuously and without errors.Compliance & Documentation
Ensure compliance with medical device regulations such as ISO 13485, FDA 21 CFR Part 820, and IEC 60601 standards.Maintain detailed documentation for reliability processes and testing.Collaborative Problem Solving
Work cross-functionally to improve product design, reduce failures, and increase overall system reliability.Continuous Improvement
Lead initiatives to continuously improve the reliability, maintainability, and performance of medical instruments and systems.What You Bring :
Educational Background :
Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field.Experience :
3-5 years of experience in reliability engineering or related roles in the medical device industry.Proven experience with FDA or ISO regulatory requirements.Technical Skills :
Knowledge of medical device safety standards (IEC 60601, ISO 14971) and regulatory frameworks (FDA 21 CFR Part 820, ISO 13485).Familiarity with reliability analysis tools and methodologies (FMEA, FTA, Weibull analysis, MTBF calculations).Experience with electromechanical systems and their reliability testing (environmental, vibration, stress testing).Strong understanding of medical device development processes, including design for reliability (DfR).Hands-on experience with data analysis, performance monitoring, and statistical tools (e.g., Minitab, MATLAB).Familiarity with software and firmware reliability for embedded systems in medical instruments.Soft Skills :
Excellent analytical, problem-solving, and troubleshooting skills.Strong communication skills and ability to work in cross-functional teams.Detail-oriented with a focus on safety and quality.Ability to manage projects and prioritize in a regulated environment.Preferred Qualifications :
Experience in systems engineering or field support for complex medical devices or instruments.Familiarity with reliability growth models and accelerated life testing.Certifications such as Certified Reliability Engineer (CRE) or Certified Biomedical Equipment Technician (CBET).Why Join Cytek?
At Cytek, you're not just ensuring reliability-you're shaping the future of medical devices and improving patient outcomes. We value innovation, collaboration, and dedication to safety and quality.
Impactful Role : Opportunity to ensure the reliability and safety of critical medical devices.Professional Growth : Develop your skills in a supportive and dynamic environment.Competitive Rewards : Competitive pay, great benefits, and a supportive team.Cytek is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment.
Ready to shape the future of medical device reliability? Apply now and make a difference!
J-18808-Ljbffr
