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Senior Regulatory Test Engineer

Waltham, Massachusetts · Science/Research
Lead the development and authoring of software Verification test plans, protocols, and reports for medical devices. Support a diverse and distributed medical device development team with requirement analysis and test strategies.  

REQUIRED SKILLS
  • Excellent written and verbal communication skills, including the ability to collect data, concisely organize information and author reports.
  • Ability to comprehend detailed software specifications and write corresponding test protocols
  • High attention to detail and ability to lead V&V efforts to timely completion
  • Able to perform well in a fast-paced, team environment
DESIRED SKILLS
  • Experience developing/configuring scripting and automation frameworks
  • Excellent understanding of software design verification and validation for medical devices.
  • Strong interpersonal skills, including the ability to work with and influence individuals of diverse backgrounds and technical ability.
  • Working knowledge in SDLC, STLC, test methodologies and defect management
  • Working knowledge of ISO 13485, IEC 62304, or IEC 62366, a plus
  • Knowledge of software programming and embedded systems, C++, a big plus.
  • Successful 510K submissions, a plus
 
DUTIES AND RESPONSIBILITIES
  • Develop and execute software/firmware verification protocols for FDA regulated medical devices
  • Participate in product requirements analysis to ensure testability
  • Develop test plans and strategies to verify design specifications
  • Review and support on engineering change requests, deviation notices, and risk management
  • Utilize issue tracking tools and other methods to ensure consistent traceability between requirements, the design and test cases
EDUCATION and/or EXPERIENCE
  • Minimum of bachelor’s degree or
  • Minimum of two (2) years related experience in a regulated software development/test environment.

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