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

Location: Raritan, New Jersey, United States; Flex/Hybrid schedule with 3 days per week on-site

Salary: $109,000–$174,800 per year

Company

Johnson & Johnson MedTech develops surgical technologies, medical devices, and data-driven solutions for less invasive and personalized treatments.

What you will do

• Lead R&D system implementation and project delivery from research questions and feasibility through study design, analysis, presentation, and publication.
• Partner with portfolio management, analytical evaluation, research science, data science, and external organizations in a matrix environment.
• Deliver scalable automated and artificial intelligence solutions that expand testing capacity and improve data collection and analysis.
• Develop data aggregation and reporting methodologies to identify trends across large datasets from LIMS, ERP, and other sources.
• Plan and execute risk-based Computer System Validation for GxP-relevant laboratory and quality systems.
• Lead validation testing, deviation investigations, non-conformances, CAPA activities, and Part 11 control assessments.

Requirements

• Bachelor’s degree in engineering, artificial intelligence, computer science, statistics, biostatistics, biomedical informatics, applied mathematics, or a similar quantitative field.
• 5+ years of experience supporting GxP computerized systems in a regulated environment, such as pharma, medical devices, biotech, or diagnostics.
• Working knowledge of 21 CFR Part 11 and ALCOA+ data integrity principles, including electronic records and signatures.
• Experience with Agile and waterfall project management, SDLC testing, requirements-to-test traceability, and test automation.
• Proven leadership of complex projects, cross-functional teams, and external vendors in a matrix organization.
• Strong information systems, communication, presentation, analytical, and mentoring skills; PPE may be required in laboratories.

Nice to have

• Master’s degree in a relevant quantitative or technical field.
• Experience with Model-Based Systems Engineering, SAP Product Lifecycle Management, software architectures, or scripting languages.

Culture & Benefits

• Work in a cross-functional R&D environment focused on surgical innovation and healthcare technology.
• Collaborate with data scientists, research scientists, technical partners, and external companies.
• Retirement pension and 401(k) savings plans are available under the applicable plans.
• Benefits include vacation, sick time, holidays, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time off.