Manager, R&D Verification & Validation (V&V) & Lab Ops

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Vision

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding on the possibilities of vision treatments Ready to join a team thats reimagining how vision is improved Our Vision team solves the toughest health challenges. Help combine cutting-edge insights science technology and people to encourage eye care professionals and patients to proactively protect correct and enhance healthy sight for life. Our products and services address these needs from the pediatric to aging eye in a patients lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for a Manager R&D Verification & Validation (V&V) and Laboratory Operations. The position is based in Irvine CA.

Purpose: The Manager R&D Verification & Validation (V&V) and Laboratory Operations leads V&V of ophthalmic devices and manages day-to-day lab and compliance activities. This people leader is responsible for overseeing the administration hiring training and development and managing the professional/performance goals of the team. The Manager R&D V&V and Labs manages people resources test planning/execution lab equipment and calibration and compliance with Quality System Regulations.

This position requires technical and leadership skills to advance the development of medical devices before and during V&V activities. Will be acting as the advisor to resolve technical or operational problems during product development. Uses current practices standards and experience to establish operating policies and procedures that are compliant with Quality System Regulations. Also responsible for managing the R&D lab equipment safety regulations equipment calibration and internal/external audits. Adheres to environmental policy procedures and supports department environmental objectives.

You will be responsible for:

• Provide quality and technical leadership to ensure new medical devices meet their intended use.
• Lead planning and execution of verification and validation for new products.
• Ensure resourcing is available to complete all assigned V&V projects.
• Collaborate with product engineering to define and review requirements design verification white-box and black-box test strategies.
• Oversee test development execution defect tracking and closure; approve test artifacts and deliverables.
• Implement and continuously improve V&V processes tools and metrics.
• Manage lab facilities: equipment procurement maintenance calibration and safety compliance.
• Lead internal and external audits and support regulatory submissions and inspections.
• Mentor and develop a multidisciplinary team; conduct performance management and hiring.
• Maintain documentation in accordance with design control and configuration management requirements.
• Ensure software risk analysis and defect management practices are in place and followed.
• Support department environmental and safety objectives.
• Engage in Credo-based decision-making and interact with team members both local and off-site.
• Drive efficiency through test automation AI onshore/offshore contract services and related initiatives
• Participate in design for test/manufacturing/reliability efforts
• Partner with reliability testing
• Have scope including hardware software and consumables
• Prioritize and execute capital spending

Qualifications:

• A Bachelors Degree in engineering is required
• 10 years of medical device test V&V and/or QA experience
• 2 years of direct people management

• Experience managing V&V teams within the Medical Device industry
• Excellent understanding of design control requirements management configuration management product software V&V defect management and software risk analysis
• Knowledge of ISOCFR 820
• Excellent organizational skills including attention to detail and multi-tasking skills is required
• Outstanding communication and presentation abilities
• Experience in project management scheduling tasking and budgeting

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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