At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com 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. **Job Function:** R&D Operations **Job Sub** **Function:** Product Development Testing **Job Category:** People Leader **All Job Posting Locations:** Irvine, California, United States of America **Job Description:** **About Vision** Fueled by innovation at the intersection of biology and technology, we’re 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 that’s 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 patient’s lifetime. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech **We 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 Bachelor’s 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 ISO 14971, 21 CFR 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 https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. \#LI-Onsite \#LI-VY1 **Required Skills:** **Preferred Skills:** Chemistry, Manufacturing, and Control (CMC), Clinical Trial Protocols, Developing Others, Give Feedback, Inclusive Leadership, Industry Analysis, Job Scheduling Software, Laboratory Operations, Leadership, Market Research, Performance Measurement, Process Improvements, Product Development, Product Strategies, Research and Development, Team Management **The anticipated base pay range for this position is :** $117,000.00 - $201,250.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year