Mirion Technologies, Inc.

Test Engineer

Mirion Technologies, Inc.$90K — $110K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Physics, or related field
  • 5+ years of experience in verification or test engineering in a regulated industry
  • Strong understanding of design controls and verification processes
  • Experience with Requirements Traceability Matrices (RTMs) and verification documentation
  • Proficient in requirements management tools, preferably Jama
  • Familiarity with ISO 14971 risk management standards
  • Exposure to test automation and related tools

Responsibilities

  • Evaluate System and Design Requirements to define verification strategies and test cases
  • Develop comprehensive verification plans detailing testing requirements
  • Create and manage verification protocols and regression test libraries
  • Analyze test results and prepare verification reports
  • Ensure compliance with requirements before design freeze
  • Support product development and manufacturing transition activities
  • Investigate returned products to identify trends or issues

Benefits

  • Not specified in the job listing.
Full Job Description
The Test Engineer is responsible for planning, developing, and executing verification activities for medical device products and systems throughout the Product Development Process (PDP). This role ensures products meet System and Design Requirements, comply with design controls, and are thoroughly verified before release. The Test Engineer collaborates closely with Systems Engineers, Physicists, and Development Engineers to support product development, design verification, and manufacturing transition activities.

Key Areas of Responsibility
  • Evaluate System and Design Requirements to define verification strategies, test cases, and performance criteria.
  • Develop verification plans, including resource, equipment, unit-under-test (UUT), and external testing requirements.
  • Create, execute, and maintain verification protocols and regression test libraries.
  • Analyze test results, document findings, and prepare verification reports and test summary documentation.
  • Verify compliance with System and Design Requirements prior to design freeze.
  • Support system integration, product development, and manufacturing transfer activities.
  • Develop Production Equivalence Assessments to ensure verification devices are production representative.
  • Coordinate test planning inputs from Systems Engineers, Physicists, and other subject matter experts.
  • Investigate returned products, collect and analyze data, and identify trends or performance issues.
  • Provide technical expertise and support for verified products and systems.
  • Delegate and monitor testing activities as needed.

Knowledge, Skills & Abilities
  • Bachelor's degree in Engineering, Physics, or a related technical field.
  • 5+ years of verification, validation, or test engineering experience in a regulated industry.
  • Strong understanding of design controls, verification processes, and product development requirements.
  • Experience developing design control documentation, including Requirements Traceability Matrices (RTMs), V&V Plans, verification protocols, and verification reports.
  • Experience analyzing System Requirements and Design Specifications.
  • Proficiency with requirements management tools (Jama preferred).
  • Understanding of Product Development Process (PDP) phases and deliverables.
  • Knowledge of ISO 14971 risk management and safety risk analysis.
  • Experience with environmental, shipping, EMC, and safety testing (IEC 60601-1, IEC 60601-1-2, IEC 61010, IEC 61326).
  • Experience with test automation and automation tools.
  • Familiarity with Windchill, JIRA, Confluence, or similar document and issue management systems.
  • Experience using verification equipment such as oscilloscopes, DMMs, environmental chambers, force gauges, and specialized medical device test equipment.
  • Experience with AI tools such as Claude or similar platforms.
  • Strong technical writing and documentation skills.

About Mirion Technologies, Inc.

Mirion Technologies, Inc. is a global provider of radiation detection and measurement solutions for a variety of industries including nuclear power, medical, and homeland security. The company's products include radiation detectors, dosimeters, and spectroscopy systems. Mirion Technologies, Inc. was founded in 1958 and is headquartered in Sophia Antipolis, France. The company has a global presence with operations in North America, Europe, and Asia. Mirion Technologies, Inc. is privately held and does not disclose its financial information.
Learn more about Mirion Technologies, Inc.
Size
2,000 employees
Market Cap
$1.3 billion
Industry
NASDAQ

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