Systems Test Engineer (Medical Devices)

Infosoft, Inc.; Newton (MA); Hybrid; USD 80,000 - 120,000; Full time

Job summary

An established industry player in healthcare diagnostics is seeking a Systems Test Engineer to enhance their medical robotics division. This role involves developing verification methods, supporting requirement traceability, and conducting thorough verification testing. The ideal candidate will have a strong background in the medical device industry, particularly with robotic systems, and will contribute to continuous improvement initiatives. With a hybrid work model, this position offers a blend of office and remote work, allowing for flexibility while ensuring collaboration. Join a team that is dedicated to advancing medical technology and improving patient outcomes.

Qualifications

• 5+ years of experience in the medical device industry, especially in robotics.
• Strong background in developing verification methods for complex systems.

Responsibilities

• Develop test methods for verification of medical robotics systems.
• Support traceability of requirements and drive quality processes.
• Conduct statistical analysis for verification testing.

Skills

Test Method Development

Verification Testing

Statistical Analysis

Traceability Management

Continuous Improvement

Medical Device Standards Knowledge

Risk Management

Education

Bachelor's Degree in Engineering

Tools

SW Tools Validation

Test Fixtures

Job description

This position is for the Healthcare Diagnostic division.

We are looking for a Systems Test Engineer.

Responsibilities:

• Developing test methods for the verification of a complex medical robotics system
• Supporting and updating the traceability of requirements and risk
• Implementation of processes in our toolchain for verification and issue management
• Execution of system and subsystem verification testing
• Drive continuous improvement for systems engineering and quality processes
• Experience developing verification methods and strategies for a complex medical device
• Working with traceability for a large set of multi-layered product requirements
• Knowledge of applicable medical device standards, such as IEC 60601-1 and collateral standards
• Implementing test method verification
• Working on complex electromechanical medical device programs through the verification and validation phases
• Determining sample size for tests based on statistical processes
• Conducting statistical analysis to determine if multi-sample tests have passed
• Validation of SW tools and test fixtures

Requirements:

• A Bachelor’s degree or equivalent experience is required in engineering disciplines, such as systems, biomedical, robotics, software, mechanical, or electrical engineering.
• 5+ years relevant technical experience in the medical device industry (medical/surgical robotics experience preferred)

Location:

Newton, MA (Hybrid - 3 days in office Monday, Tuesday, and Thursday. In the future, during periods of verification testing, full-time in-office may be needed)

Seniority level:

Mid-Senior level

Employment type:

Contract

Job function:

Robot Manufacturing, Robotics Engineering, and Medical Equipment Manufacturing