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Sr. Instrument Verification and Validation Engineer

Sr. Instrument Verification and Validation Engineer

Katalyst HealthCares & Life SciencesRochester, NY
16 days ago
Job type
  • Full-time
Job description

Responsibilities :

  • Designing and implementing software of embedded devices and systems.
  • Designing, developing, coding, testing, and debugging system software.
  • Develop Requirements based manual test procedures.
  • Access requirements for testability and determine best test approach.
  • Compile and analyze test results.
  • Document and manage system software defects.
  • Participate in regular scheduling and team meetings.
  • Participate in regular off hour meetings with partner in China.
  • Understand project goals and timelines, and provides support to ensure product launch success.
  • Perform other work- related duties as assigned.

Requirements :

  • or Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline required.
  • years required, preferably in a medical device environment.
  • Familiarity with software configuration management tools, defect tracking tools, and peer review.
  • Instrument V&V Theory & Application.
  • An understanding of IEC (Medical Device Software – Lifecycle process), ISO , ISO / EN ISO , and FDA QSR experience or equivalent FDA software development requirements.
  • Good analytical and problem-solving skills.
  • Good organizational skills, and the ability to manage multiple tasks.
  • Experience in product development and experimental design.
  • Ability to work within cross-functional teams.
  • Strong communication skills, written and verbal.
  • Must exhibit professionalism, confidence, maturity, desire to succeed, and a self-motivated and proactive orientation.
  • Ability to participate in planning and managing projects.
  • Working knowledge of product development tools and processes ( Design Input, Design Output, Verification and Validation, Product Risk Management).
  • Knowledge of related quality systems regulations and processes.
  • Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software).
  • Knowledge of Application life cycle management (Agile method preferred).
  • Know and understand the software test cycle.
  • Ability to write test plans, test cases and test reports.
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    Sr Validation Engineer • Rochester, NY