Job Title: Sr. Software V&V Engineer

Pay rate: $45 - $50 per hour

Duration: Until 12-31-2025

W2 contract only (No C2C)

Location- 100 Indigo Creek Drive - Rochester, NY

Description

• 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.
• 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

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
• This position is not currently eligible for visa sponsorship