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.
This is a hybrid position that can be based in Boston, MA or Warsaw, IN, joining the Orthopaedics team.
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-tiered 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, the Orthopaedics team is developing the next generation of smarter, less invasive, more personalized treatments. The team helps keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems, building solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.
Note on Business Separation
Johnson & Johnson announced plans to separate its 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.
Preferred Skills
Analytical Reasoning, Consulting, Data Structures, Digital Fluency, Digital Strategy, Emerging Technologies, Engineering, Global Market, Negotiation, Product Development, Product Improvements, Project Schedule, Regulatory Compliance, Research and Development, SAP Product Lifecycle Management, Tactical Planning, Technical Credibility, Technologically Savvy
Pay
The anticipated base pay range for this position is $140,000.00 - $241,500.00.
Benefits
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
•Vacation – 120 hours per calendar year
•Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
•Holiday pay, including Floating Holidays – 13 days per calendar year
•Work, Personal and Family Time - up to 40 hours per calendar year
•Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
•Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
•Caregiver Leave – 80 hours in a 52-week rolling period
•Volunteer Leave – 32 hours per calendar year
•Military Spouse Time-Off – 80 hours per calendar year
