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

jj

Raritan (NJ)

Hybrid

USD 120,000 - 175,000

Full time

8 days ago

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Job summary

Johnson & Johnson MedTech in Raritan, NJ is seeking a Systems Implementation Lead & Project Manager for R&D. You will lead data science and validation efforts across GxP systems, guiding cross-functional teams and external vendors to deliver compliant, scalable solutions for laboratory and clinical workflows.

This role blends technical leadership with program management in a fast-paced environment. This position requires a quantitative degree, 5+ years in regulated environments, and experience

Qualifications

Bachelor’s degree in a quantitative field is required; Master’s preferred.
5+ years’ experience supporting GxP computerized systems in regulated environments.
Knowledge of 21 CFR Part 11 and data integrity principles (ALCOA+).
Experience with Agile and waterfall project management.

Responsibilities

Lead cross-functional teams and external vendors to deliver data-driven solutions.
Plan, design, and manage validation activities for GxP systems.
Communicate technical results to diverse audiences to drive decisions.
Develop automation and data aggregation strategies across testing areas.

Skills

Project leadership

Cross-functional collaboration

Agile + Waterfall PM

Data governance

Communication skills

GxP systems knowledge

Regulatory awareness

Problem solving

Stakeholder management

Education

Bachelor’s degree in quantitative field

Master’s degree preferred

Tools

SAP PLM

Scripting Languages

MBSE

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 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.

Required 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

Preferred Skills

The anticipated base pay range for this position

$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)).

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

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

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