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QuidelOrtho · 1 day ago

Staff Software Reliability and V&V Engineer (Lead)

Rochester, NY

Full-time

Onsite

Senior Level, Lead/Staff

$120K/yr - $140K/yr

7+ years exp

QuidelOrtho is a world-leading in vitro diagnostics company focused on providing accurate and consistent testing solutions. The Staff Software Reliability and V&V Engineer will lead engineering teams in the verification and validation of complex medical devices, ensuring compliance with FDA regulations and maintaining product quality standards.

Medical Device

No H1B

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

Qualification

V&V skillsMedical device experienceSoftware configuration managementRegulatory compliance knowledgeProduct developmentExperimental designProject managementCross-functional teamworkPeople managementCoachingProfessionalismProblem-solvingAttention to detailCommunication skillsMentoringSelf-motivated

Required

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

Benefits

Comprehensive benefits package including medical, dental, vision, life, and disability insurance

401(k) plan

Employee assistance program

Employee Stock Purchase Plan

Paid time off (including sick time)

Paid Holidays

Company

QuidelOrtho

Glassdoor3.5

> Bringing precision and passion in everything we do QuidelOrtho stands at the forefront of testing, tracking and disease analysis of health conditions ranging from HIV and hepatitis C to flu, strep and COVID-19.

Founded in 1937

5001-10000 employees