Overview
Junior R&D Project Engineer Jobs in Raritan, NJ at Raas Infotek
Title: Junior R&D Project Engineer
Company: Raas Infotek
Location: Raritan, NJ
Position Name: R&D Project Engineer
Location: Raritan, NJ
NEED Junior profile and remote option is available here..
Job Description:
• Provide R&D LCM support to the MDR franchise initiative to successfully close applicable Design History Files (DHF) leading to the implementation of MDR compliant product families in the applicable ETHICON manufacturing sites.
• Provide R&D LCM support in the manual data collection for EUDAMED UDI per approved protocol and work with cross functional team for all Ethicon Product families as required.
• Engage with the cross-functional team members as required to ensure proper documentation is developed and approved in the PLM system as well as escalation of any concerns, issues or delays to Ethicon management.
• Ensure to complete all required assigned training courses on time.
Experience:
Experience in medical device R&D, regulatory, or quality roles
Experience in JnJ and Adaptiv is highly preferred
Proven experience leading cross functional projects
Hands-on experience with EU MDR requirements
Exposure to EUDAMED submissions or data preparation is highly preferred
Knowledge & Skills:
Technical & Regulatory
Strong understanding of EU MDR and medical device lifecycle requirements
Knowledge of Design Controls, Risk Management (ISO 14971), and Clinical Evaluation
Familiarity with UDI requirements and medical device data structures
Project & Leadership Skills
Strong project management skills (planning, risk management, stakeholder communication)
Ability to work in a matrix organization
Excellent problem solving and decision making capabilities
Communication & Tools
Clear written and verbal communication skills
Experience with project management and document management systems
Comfortable working with regulatory databases and structured data submissions
Behavioral Competencies
Detail oriented with strong compliance mindset
Proactive and adaptable in regulatory driven environments
Collaborative team player with a continuous improvement approach
Education
Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or related field
