Senior Software Instrument Verification and Validation Engineer (Lead)
About The Position
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. As we continue to grow as QuidelOrtho, we are seeking a Senior Software Instrument 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 in Rochester, NY (100 Indigo Creek Drive).
Requirements
- B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline required.
- Minimum of 8 years required, preferably leading in a medical device environment.
- Strong knowledge of software configuration management tools, defect tracking tools, and peer review
- Strong understanding of Instrument V&V Theory & Application
- 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 analytical and problem-solving skills
- Strong organizational skills and the ability to manage multiple tasks
- Experience in product development and experimental design
- Ability to work within cross-functional teams
- Strong communication skills, written and verbal
- 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.
- Must have the ability to write test plans, test cases, and test reports.
Responsibilities
- Manage V&V resources with testing and debugging system software, serving 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
- Compilation and analysis of test results
- Documentation and management of system software defects
- Lead in regular scheduling, planning, resourcing, and team meetings
- 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
- Provides critical oversight in resolving field issues and maintaining product integrity throughout the lifecycle
- Mentor and develop team members to help them grow professionally
- Perform other work-related duties as assigned.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
