Sr. Instrument Verification and Validation Engineer Position Available In Monroe, New York

Sr. Instrument Verification and Validation Engineer

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. Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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Dice Id:

91116760

Position Id:

6edf3dad9cced81a677cd57b87b43b5