Lead Clinical R&D Engineer, Joint Robotics (Hybrid)

Biopharma Asia; Warsaw (IN); Hybrid; USD 140,000 - 242,000; Full time

Benefits offered by this job

Pension plan

401(k) retirement savings

Paid time off

Parental Leave

Job summary

Johnson & Johnson in the United States and Warsaw seeks a Senior Principal Clinical R&D Engineer - Joints Robotics to lead cross-functional development in orthopedics. This hybrid role can be based in Boston, MA or Warsaw, IN.

You will bridge medical device design, patient safety, regulatory compliance, and clinical applications across the product lifecycle, influencing risk management and documentation with surgeons and QA teams.

Qualifications

• Bachelor's degree in Engineering (mechanical, biomedical, electrical, or related).
• 12+ years of medical device R&D, clinical engineering, or related roles supporting product development.
• Demonstrated ability to collaborate across engineering, clinical, quality, and regulatory teams.
• Strong written and verbal communication skills and practical problem solving ability.
• Direct experience in orthopedics, joint replacement, or surgical robotics.
• Knowledge of regulatory pathways (FDA, EU MDR).
• Experience with field actions, complaint investigations, HHAs, and recall processes.

Responsibilities

• Help Gather and Translate Voice of Customer (VoC) insights into clinical and engineering scope proposals.
• Support “train the trainer” and R&D roll outs.
• Support surgeon and clinical staff interactions and demos.
• Support high-tired clinical investigation at times of need.
• Advise on usability.
• Partner with Regulatory to draft and support technical and clinical documentation for regulatory submissions and post market reporting.
• Review field actions, product complaints, health hazard assessments (HHAs), and recall decisions; provide technical/clinical risk assessments and remediation recommendations.

Skills

Communication skills

Cross-functional collaboration

Regulatory knowledge

Clinical engineering

Orthopedics experience

Problem solving

Education

Bachelor's degree in Engineering

Job description

Johnson & Johnson in the United States and Warsaw seeks a Senior Principal Clinical R&D Engineer - Joints Robotics to lead cross-functional development in orthopedics. This hybrid role can be based in Boston, MA or Warsaw, IN.

You will bridge medical device design, patient safety, regulatory compliance, and clinical applications across the product lifecycle, influencing risk management and documentation with surgeons and QA teams.