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Sr. Instrument Verification and Validation Engineer

Sr. Instrument Verification and Validation Engineer

Katalyst HealthCares and Life SciencesRochester, NY, US
30+ days ago
Job type
  • Full-time
Job description

Job Description :

  • Client is seeking a Verification and Validation SR Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will be part of an engineering team that is responsible for requirements based manual test case design and execution of test procedures in a BL2 lab environment.
  • The team is highly collaborative and will require regular interactions in formal reviews, test planning activities, and working with software development and partners to reproduce and verify system defects.
  • The job is 100% onsite at 100 Indigo Creek Drive (CNP location). Occasional travel required. The 20% travel includes airplane, automobile travel and overnight hotel.

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 :

  • B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline required.
  • 10+ 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 62304 (Medical Device Software - Lifecycle process), ISO 13485, ISO / EN ISO 14971, 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 (e.g. 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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