Senior Principal Clinical R&D Engineer - Joints Robotics

Johnson & Johnson Co.; Warsaw (IN); Híbrido; USD 150 000 - 210 000; Tempo integral

Resumo da oferta

Johnson & Johnson is seeking a Senior Principal Clinical R&D Engineer - Joints Robotics to lead clinical engineering efforts across orthopedic robotics, bridging design, safety, and regulatory compliance.

This hybrid role can be based in Boston, MA or Warsaw, IN, requiring deep collaboration with engineering, clinical, quality, and regulatory teams to deliver safe, effective medical devices throughout the product lifecycle.

Qualificações

• Bachelor's degree in Engineering (mechanical, biomedical, electrical, or related).
• 12+ years' experience in medical device R&D, clinical engineering, or related roles supporting product development.
• Experience collaborating across engineering, clinical, quality, and regulatory teams.
• 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.

Responsabilidades

• Translate Voice of Customer insights into clinical and engineering scope proposals.
• Support regulatory submissions and post‑market reporting.
• Review field actions, product complaints, HHAs, and recall decisions; provide risk assessments.
• Assist with preparation of technical sections for manuscripts and internal technical reports.

Conhecimentos

R&D leadership

Regulatory liaison

Clinical collaboration

Cross-functional influencer

Orthopedics exposure

Formação académica

Bachelor's degree in Engineering

Descrição da oferta de emprego

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

Job Category

Scientific/Technology

All Job Posting Locations

Boston, Massachusetts, United States of America, Warsaw, Indiana, United States of America

Job Description

We are searching for the best talent for a Senior Principal Clinical R&D Engineer - Joints Robotics to join our Orthopaedics team. This is a hybrid position that can be based in Boston, MA or Warsaw, IN.

Purpose

This role will act as a senior technical and clinical leader who bridges medical device design, patient safety, regulatory compliance, and real‑world clinical applications for joint robotics. You will provide hands‑on engineering and clinical input across the product lifecycle to ensure safe, effective, and compliant device development.

Key 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. - Interface directly with physicians, clinical staff, quality assurance, regulatory affairs, and external testing laboratories to resolve technical and clinical questions.
• Support preparation of technical sections for scientific manuscripts, clinical summaries, and internal technical reports at need.

Required Qualifications

• Bachelor's degree in Engineering (mechanical, biomedical, electrical, or related) or equivalent technical degree.
• 12+ years' experience in 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. Preferred / desired qualifications
• 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.
• OR exposure and strong clinician relationships.
• Technical leadership with clinical focus
• pragmatic
• data driven decision maker.
• Collaborative communicator and cross functional influencer.
• Patient outcomes and risk management oriented.

About Orthopaedics

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 Orthopaedics? Ready to join a team that's reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you