Technical Manager

Job Summary

R&D Project Lead (Onsite) with 10+Yrs of Experience (E2.2/E3.1)

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

Key Responsibilities

• 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.

Skill Requirements

• 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

• Strong project management skills (planning, risk management, stakeholder communication)

• Ability to work in a matrix organization

• Excellent problem‑solving and decision‑making capabilities

• Clear written and verbal communication skills

• Experience with project management and document management systems

• Comfortable working with regulatory databases and structured data submissions

• Detail‑oriented with strong compliance mindset

• Proactive and adaptable in regulatory‑driven environments

• Collaborative team player with a continuous improvement approach

Other Requirements

EDUCATION:

Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or related field

Master’s degree is a plus