Staff Software Reliability and V&V Engineer (Lead)

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

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).

The 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

The Individual

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. 

The Key Working Relationships

Internal Partners:

• Software Development, Software Integration, Marketing, Quality, and Project Management

External Partners:

• Software Development partners

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Including walk-in fridges/freezer. Up to 60% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines

Physical Demands

A job description should include physical demands that are essential to the job's performance to comply with the American with Disabilities Act (ADA). Physical demands are the level and duration of physical exertion needed to perform critical tasks, such as: 

sitting, standing, walking, lifting, carrying, reaching, pushing, and pulling. Other physical demands include: 

• Bending 
• Crawling 
• Stooping 
• Vision 
• Climbing or balancing 
• Kneeling 
• Crouching 
• Talking or hearing 
• Tasting or smelling 

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $120,000 to $140000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected].