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

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 publication
• Be able to advise and contribute to projects outside of their responsibilities and collaborate with research scientists in diverse projects
• Deliver 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 companies
• Lead 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 sets
• Be 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 areas
• Clearly articulate highly technical methods and results to diverse audiences and partners to drive decision-making
• Responsible for communicating business related issues or opportunities to next management level
• Responsible 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 procedures
• Performs other duties assigned as needed
• Specific tasks to be expected are
• Computer 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.

• 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 preferred
• 5+ 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 projects
• Demonstrated experience in leading cross-functional teams and managing external vendors is required .
• Ability to work in an agile matrix environment
• Excellent interpersonal, communication, and presentation skills
• Proficiency in Information Systems is required
• Ability to effectively communicate technical work to a wide audience
• May be required to wear PPE when entering laboratories, 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 Savvy

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

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., 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 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 https://www.jnj.com/medtech

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.