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

Antler Co; Raritan (NJ); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation –120 hours/year

Sick time – 40 hours/year

Holiday pay

Job summary

Johnson & Johnson MedTech seeks a Systems Implementation Lead & Project Manager in Raritan, NJ, to steer R&D data initiatives with 3 days on-site. You’ll drive automated data solutions, CSV validation, and cross-functional collaboration across scientific teams worldwide.

Requires 5+ years in regulated environments, strong knowledge of 21 CFR Part 11, and experience with Agile/Waterfall PM. Hybrid work schedule with on-site presence in NJ is offered.

Qualifications

• Bachelor’s degree in a quantitative field required; Master’s preferred.
• 5+ years in regulated environments (pharma/medical device) for GxP computerized systems.
• Experience with Agile and waterfall project management.
• Knowledge of data integrity concepts and electronic records/e-signatures.

Responsibilities

• Lead data science projects and manage cross-functional teams.
• Develop validation plans and traceability for CSV & QA activities.
• Plan and execute risk-based validation for GxP systems.
• Design test cases across SDLC phases and ensure traceability.
• Mentor junior data scientists and promote best practices.

Skills

GxP data systems knowledge

Agile project management

Cross-functional leadership

Data science / analytics

Communication excellence

Matrix environment experience

Education

Bachelor’s degree in engineering or related quantitative field

Master’s degree preferred

Tools

SAP Product Lifecycle Management

21 CFR Part 11 knowledge

Job description

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 Product Development

Job Sub Function

R&D Software/Systems Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Raritan, New Jersey, United States of America

Job Description

About Surgery

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 and 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

• 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.

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 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

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.

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 Savvy

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

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)).

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
• For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits