Senior Reliability Engineer – Medical Devices

Sapsol Technologies Inc; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Sapsol Technologies Inc. is seeking an experienced Reliability Engineer to lead the development of reliability requirements and test plans for regulated medical device hardware.

The role involves DFMEA, FRACAS, and collaboration with R&D, QA, and manufacturing to ensure product reliability across lifecycle stages. Qualified candidates bring 10+ years in reliability engineering within regulated environments, strong regulatory knowledge (ISO/FDA), and proficiency with reliability tools like

Qualifications

• Bachelor's degree in Mechanical / Electrical / Reliability Engineering or a related discipline.
• 10+ years reliability engineering experience in highly regulated industries, preferably medical devices.
• Experience creating custom verification tests and fixtures.
• Experience planning verification tests (DoE, sample size, etc.).
• Strong regulatory knowledge across medical device standards (ISO 13485, FDA 21 CFR 820, IEC 60601, 62304, 62366-1, 10993, 17025).
• Experience with reliability data analysis tools (Reliasoft, Minitab, JMP) and programming languages (Python/Matlab/R) is preferred.

Responsibilities

• Develop reliability requirements and ensure cascade into test plans.
• Lead and facilitate DFMEA/FRACAS across projects.
• Design and develop test methods and fixtures for IVD devices.
• Write test protocols and train staff on procedures.
• Conduct reliability tests (environmental, lifecycle, aging) per regulatory standards.
• Analyze results and report findings with risk assessment.
• Serve as reliability engineering SME in cross-functional teams.
• Recommend design/test methods and SPC procedures to achieve reliability goals.
• Lead multiple projects in a fast-paced environment.
• Support DFx processes and assist in defining reliability plans.

Skills

Reliability engineering

HALT/HASS/ALT

Weibull modelling

Minitab/JMP

Python/Matlab/R

DFMEA

PFMEA

Fault tree analysis

Accelerated life testing

Education

Bachelor's degree in Mechanical / Electrical / Reliability Engineering or related discipline

Tools

Reliasoft

Windchill

Minitab

Job description

Sapsol Technologies Inc. is seeking an experienced Reliability Engineer to lead the development of reliability requirements and test plans for regulated medical device hardware.

The role involves DFMEA, FRACAS, and collaboration with R&D, QA, and manufacturing to ensure product reliability across lifecycle stages. Qualified candidates bring 10+ years in reliability engineering within regulated environments, strong regulatory knowledge (ISO/FDA), and proficiency with reliability tools like