This range is provided by iSpace, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range$120,000.00/yr - $140,000.00/yrStaff Instrument Reliability Verification and Validation EngineerFull-Time Employment with CLIENTSalary $120k to $140k + BenefitsJob DescriptionCandidates Must sit in Rochester, NY (100% on-site)Candidates ideally have led and/or management experience – being able to work cross functionally is important.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.ResponsibilitiesManage two separate Teams, oversee reliability and V&V planning, resourcing, and schedules to ensure on‑time completion of milestonesDrive design control efforts, including writing instrument design control documentation and reviewing as necessary (Plans, Protocols & Reports) to ensure regulatory complianceEvaluate project risks and issues and provide recommendations to resolve challenges impeding successDesign, develop, code, test, and debug system software serving as a technical bridge between software Development and V&VEnsure rigorous adherence to design control documentation and internal procedures for post‑launch activities, maintaining regulatory compliance and product quality standardsDevelop requirements‑based manual test proceduresAssess requirements for testability and determine the best test approachCompile and analyze test resultsDocument and manage system software defectsParticipate in regular off‑hour meetings with the business partnerUnderstand project goals and timelines, and provide technical leadership to ensure product launch successEnsure optimal resource allocation and timely project completion while maintaining quality standardsMentor and develop team members to help them grow professionallyProvide critical oversight in resolving field issues and maintaining product integrity throughout the lifecyclePerform other work‑related duties as assignedIndividual (Qualifications)B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or related discipline required.15+ years experience, 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 review.Understanding of IEC 62304, ISO 13485, ISO/EN ISO 14971, and FDA QSR or equivalent FDA software development requirements.Strong organizational & communication skills, people management skills, and ability to manage multiple projects, prioritize tasks, and manage competing priorities effectively.Experience in product development and experimental design.Ability to work within cross‑functional teams.Professional, confident, mature, desire to succeed, and a self‑motivated and proactive orientation.Ability to participate in planning and managing projects.Strong working knowledge of product development tools and processes (e.g., Design Input, Design Output, Verification & Validation, Product Risk Management).Strong 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).Understand and execute software test cycle.Coach and mentor junior staff, provide technical leadership to cross‑functional project teams.10% travel includes airplane, automobile travel, and overnight hotel.Not currently eligible for visa sponsorship.Key Working RelationshipsInternal Partners:Software Development, Software Integration, Marketing, Quality, and Project ManagementExternal Partners:Software Development partnersIf you're interested in above role please send me your updated resume to chakravarthi.savalam@ispace.com#J-18808-Ljbffr