System Implementation Lead & Project Manager, R&D - MedTech

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.comAs 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 Product DevelopmentJob Sub Function: R&D Software/Systems EngineeringJob Category:Scientific/TechnologyAll Job Posting Locations:Raritan, New Jersey, United States of AmericaJob Description:About SurgeryFueled 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 the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease, and cancer. Patients are waiting.Your unique talents will help patients on their journey to wellness. Learn more at Johnson & Johnson MedTech is currently recruiting for a Systems Implementation Lead & Project Manager, R&D - MedTech. The position is in Raritan, NJ& will work a Flex/Hybrid schedule with 3 days per week on-site.The Johnson & Johnson MedTech business offers a broad range of products, platforms and technologies including sutures, topical skin adhesives, hemostasis products, surgical staplers, trocars, energy devices, and synthetic mesh devices-used in a wide variety of open and minimally invasive surgical procedures. Specialties include cardiovascular, orthopedics, support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer, and obesity. The portion of Johnson & Johnson MedTech, Inc. based in Raritan, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery.Purpose:The R&D Data Science & Management team within Ethicon R&D Advanced Evaluation develops innovative laboratory solutions leveraging a variety of different data sources across testing areas.The System implementation Lead & Project Manager will lead the team(s) responsible for developing cutting-edge methodologies to drive critical global rapid regulatory approaches and development decisions by positively impacting the way Ethicon conducts data collection and analysis.Key Responsibilities:In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:Independently partner with the Ethicon R&D Portfolio Management and Analytical Evaluation teams to execute on the priorities, building a roadmap to deliver the data supporting projects from conceptualizing the research questions, data feasibility, study design and analysis to final presentation to senior cross-functional leaders and publicationBe able to advise and contribute to projects outside of their responsibilities and collaborate with research scientists in diverse projectsDeliver scalable automated solutions and insights to impact functions and testing areas within R&D and participate in cross-functional collaborations with internal scientific and data science teams, and external companiesLead and contribute to automated solutions and artificial intelligence solutions to accelerate and enable testing capacity Leverage emerging scientific and technological developments to generate new research ideas, solutions and initiatives using multiple data sources. (LIMS, ERP, others)Provide thought leadership for developing, adapting, and delivering data aggregation/reporting methodologies to identify trends from large data setsBe a hands-on technical leader among the Data Science team, helping institute best practices while crafting a data-driven culture, developing, and mentoring more junior members of the team while advocating for skill development, working alongside a robust team of data scientists, bringing fresh perspectives and scientific rigor across Data Science projects and product material areasClearly articulate highly technical methods and results to diverse audiences and partners to drive decision-makingResponsible for communicating business related issues or opportunities to next management levelResponsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and proceduresPerforms other duties assigned as neededSpecific tasks to be expected areComputer System Validation (CSV): Plan and execute risk-based validation activities (e.g., validation plans, user requirements, traceability, testing, and summary reports) for GxP-relevant systems supporting laboratory and quality processes.Design, author, and manage test cases across SDLC phases (unit/sprint testing, integration, system, UAT, and SAT); maintain requirements-to-test traceability.Support test automation strategy: identify candidates for automation, author automation scripts (where applicable), and maintain automated test suites to support regression and release readiness.Lead/participate in deviation investigations, non-conformances and CAPA related to computerized systems, data integrity, and validation gaps.Assess and document Part 11 applicability and controls (e.g., electronic records/e-signatures), including data audit trails, system audit trails, system access, unique user IDs, and electronic signature meaning.Qualifications and Requirements:A bachelor’s degree in a quantitative field (e.g., engineering, artificial intelligence, computer science, statistics, biostatistics, biomedical informatics, applied mathematics, or similar) is required. Master’s degree preferred5+ years’ experience supporting GxP computerized systems within a regulated environment (e.g., pharma, medical device, biotech, diagnostics) is required.Working knowledge of 21 CFR Part 11 and data integrity principles (e.g., ALCOA+), including electronic records and electronic signatures is required.Experience with both Agile and waterfall style project management is required.Proven project leadership in complicated context, able to influence and engage the strategic and technical partners in a matrix organization is required.Proven track record of consistently delivering on high impact data science projectsDemonstrated experience in leading cross-functional teams and managing external vendors is required.Ability to work in an agile matrix environmentExcellent interpersonal, communication, and presentation skillsProficiency in Information Systems is requiredAbility to effectively communicate technical work to a wide audienceMay be required to wear PPE when entering laboratoriesJohnson & 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.#LI-HybridRequired Skills:Preferred Skills:Agility Jumps, Analytical Reasoning, Coaching, Collaboration, Critical Thinking, Model-Based Systems Engineering (MBSE), Product Design, Report Writing, Requirements Analysis, Research and Development, SAP Product Lifecycle Management, Scripting Languages, Software Architectures, Software Development Management, Software Engineering Practices, Software Quality Assurance (SQA), Systems Development Lifecycle (SDLC), Technologically SavvyThe anticipated base pay range for this position is :$109,000.00 - $174,800.00Additional 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 yearSick 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 yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - Raritan, New Jersey, United States of AmericaType: Full time