Staff Instrument Reliability Verification and ...

Staff Instrument Reliability Verification and Validation Engineer Location: Rochester, NY Full-Time Employment with CLIENT Hybrid Work (4 days on-site) w/ one day remote (flexible on which day) Job Description Candidates Must sit in Rochester, NY (4 days on-site) w/ one day remote (flexible on which day) -Candidates ideally have led and/or management experience - being able to work cross functionally is important.The Role: As we continue to grow as clients, we are seeking a Staff Instrument Reliability Verification and Validation Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will lead and 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 Responsibilities: Manage two separate Teams, oversee reliability and V&V planning, resourcing, and schedules to ensure on-time completion of milestonesDrives design control efforts, including writing instrument design control documentation and reviewing as necessary (Plans, Protocols & Reports) to ensure regulatory complianceEvaluates project risks and issues and provides recommendations to resolve challenges impeding successDesigning, developing, coding, testing, and debugging system software serves as a technical bridge between software Development and V&VEnsures rigorous adherence to design control documentation and internal procedures for post-launch activities, maintaining regulatory compliance and product quality standardsThe development of requirements-based manual test proceduresIn accessing requirements for testability and determining the best test approachCompilation and analysis of test resultsDocumentation and management of system software defectParticipate in regular off-hour meetings with the business partnerUnderstand project goals and timelines, and provide technical leadership to ensure product launch successEnsures optimal resource allocation and timely project completion while maintaining quality standardsMentor and develop team members to help them grow professionallyProvides critical oversight in resolving field issues and maintaining product integrity throughout the lifecyclePerform other work-related duties as assignedThe Individual: Required:B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline required.15+ years required, preferably a minimum of 10 years leading a large team in a medical device environment.Excellent problem-solving and troubleshooting, and V&V skills to eliminate Risks, attention to detail.Strong knowledge of software configuration management tools, defect tracking tools, and peer reviewAn understanding of IEC 62304 (Medical Device Software - Lifecycle process), ISO 13485, ISO / EN ISO 14971, and FDA QSR experience or equivalent FDA software development requirementsStrong organizational & communication skills, people management skills, and the ability to manage multiple projects, ability to prioritize tasks, and manage competing priorities effectivelyExperience in product development and experimental designAbility to work within cross-functional teamsMust exhibit professionalism, confidence, maturity, desire to succeed, and a self-motivated and proactive orientation.Ability to participate in planning and managing projectsStrong working knowledge of product development tools and processes (e.g., Design Input, Design Output, Verification and Validation, Product Risk Management)Strong knowledge of related quality systems regulations and processesAppropriate computer skills (e-mail, word processing, statistical, spreadsheet, and graphing software)Knowledge of Application life cycle management (Agile method preferred).Must know and understand the software test cycle.Coaches and mentors junior staff, provides technical leadership to cross-functional project teamsThe 10% travel includes airplane, automobile travel, and overnight hotel Include title, an overview of the position, and location (onsite, hybrid, on the road, etc).This position is not currently eligible for visa sponsorship.The Key Working Relationships: Internal Partners:Software Development, Software Integration, Marketing, Quality, and Project ManagementExternal Partners:Software Development partners

Created: 2025-10-02