Staff Software Reliability and V&V Engineer (Lead)

QuidelOrtho Corporation•Rochester, NY

53d•$120,000 - $140,000•Onsite

About The Position

As we continue to grow as QuidelOrtho, 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 job is 100% onsite at 100 Indigo Creek Drive (CNP location).

Requirements

Technical Degree (BS/BA) in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline or equivalent experience.
Minimum 7 years of prior relevant experience leading a large team in medical device environments.
Advanced degree (Master's) and a minimum of 5 years or related experience.
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
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
Strong organizational & communication skills, people management skills, and the ability to manage multiple projects, ability to prioritize tasks, and manage competing priorities effectively
Experience in product development and experimental design
Ability to work within cross-functional teams
Must exhibit professionalism, confidence, maturity, 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 and 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).
Must know and understand the software test cycle.
Coaches and mentors junior staff, provides technical leadership to cross-functional project teams
The 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.

Responsibilities

Manage two separate Teams, oversee reliability and V&V planning, resourcing, and schedules to ensure on-time completion of milestones
Drives design control efforts, including writing instrument design control documentation and reviewing as necessary (Plans, Protocols & Reports) to ensure regulatory compliance
Evaluates project risks and issues and provides recommendations to resolve challenges impeding success
Designing, developing, coding, testing, and debugging system software serves as a technical bridge between software Development and V&V
Ensures rigorous adherence to design control documentation and internal procedures for post-launch activities, maintaining regulatory compliance and product quality standards
The development of requirements-based manual test procedures
In accessing requirements for testability and determining the best test approach
Compilation and analysis of test results
Documentation and management of system software defect
Participate in regular off-hour meetings with the business partner
Understand project goals and timelines, and provide technical leadership to ensure product launch success
Ensures optimal resource allocation and timely project completion while maintaining quality standards
Mentor and develop team members to help them grow professionally
Provides critical oversight in resolving field issues and maintaining product integrity throughout the lifecycle
Perform other work-related duties as assigned