Reliability Engineer - Medical Device / IVD

Reliability Engineer - Medical Device / IVD

Work Model: Onsite

Employment Type: Full-time

We are hiring a Reliability Engineer with experience in IVD, medical device, MedTech, or regulated hardware products. This role will support reliability planning, test strategy, design validation, and reliability analysis for medical device product development.

Responsibilities

• Develop reliability requirements, reliability plans, and test strategies for IVD / medical device products
• Work with R&D, quality, and manufacturing teams to design and execute reliability test plans
• Lead DFMEA activities and support Design for Reliability processes
• Conduct environmental, lifecycle, accelerated aging, and product reliability testing
• Analyze reliability test data, prepare reports, and recommend design or process improvements
• Support root cause analysis, failure investigation, and reliability validation activities

Required Qualifications

• 4+ years of product reliability or core reliability engineering experience
• Experience in medical device, MedTech, IVD, diagnostics, or regulated hardware products
• Strong experience with reliability testing, accelerated life testing, and life data analysis
• Hands-on knowledge of DFMEA, PFMEA, fault tree analysis, DOE, and root cause analysis
• Experience with statistical modeling such as Weibull and lognormal analysis
• Experience using Minitab, JMP, ReliaSoft, or similar reliability/statistical tools
• Knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820, or other medical device regulations
• Experience creating test protocols, fixtures, verification tests, and final reliability reports

Preferred Qualifications

• Experience with Python, MATLAB, or R for data analysis
• Advanced degree in Mechanical Engineering, Electrical Engineering, Reliability Engineering, or a related field
• Experience with IEC 60601, IEC 62304, IEC 62366-1, ISO 10993, EU MDR, or IVDR
• Experience with FRACAS systems and failure investigation documentation