Job Function:
R&D Product Development

Job Sub Function:
R&D Software/Systems Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Boston, Massachusetts, United States of America, Raynham, Massachusetts, United States of America

Job Description:

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

We are searching for Staff Clinical Engineer to be based out of Boston, Massachusetts, USA or Raynham, Massachusetts with in office expectations of a minimum of 3 days per week.

Purpose:

The Staff Clinical Engineer will work closely with product development teams and clinicians to drive early-stage ideas into high-impact, clinically relevant devices and features that redefine surgical robotics and navigation for orthopedics. The Staff Clinical Engineer will accelerate the transfer of breakthrough technologies from concept to clinical application, ultimately improving patient outcomes and expanding market leadership. Their primary focus is to provide clinical and technical expertise to inform user needs, clinical requirements, and real-world performance considerations in order to deliver safe, effective, and differentiated solutions. This role also supports other cross-functional teams, external research institutions, and industry partners, acting as a catalyst for disruptive innovation and continuous product improvement by providing clinical and scientific expertise throughout the product lifecycle, ensuring post-commercial performance meets the design intent.

Job Responsibilities:

• Contribute clinical and technical expertise to the ideation, conceptualization, and early-stage evaluation of novel design concepts.
• Support projects through feasibility assessment and prototype development, ensuring alignment with clinical needs and applicable regulatory pathways.
• Support the preparation and delivery of prototype and product demonstrations for internal stakeholders, customers, and external partners.
• Collaborate with HEMA, marketing, R&D and medical affairs to define the patient journey and product maps
• Drive clinical and operational quantitative needs to increase innovation value
• Lead the creation of clinical hazard analyses and procedure-specific risk maps to inform project scope and streamline timelines.
• Stay at the forefront of Computer Assisted Orthopedic Surgery by evaluating emerging trends in surgical robotics, other navigated devices and emerging surgical techniques.
• Translate insights into actionable project goals and provide input to prototype development activities that maintain competitive advantage.
• Identify critical tasks, potential use errors, and hazardous situations in clinical contexts.
• Collaborate with systems engineering to design test methods, models, and metrics to ensure test protocols and validation activities reflect realistic clinical scenarios and user profiles.
• Analyze clinical workflows, environments, and pain points to inform system concepts and architecture.
• Conduct observation studies to identify pain points, inefficiency and complications.
• Gather Voice of the Clinician (VoC) and clinical insights to help identify unmet clinical needs and translate them into system-level opportunities and requirements.
• Support Voice of Customer sessions with surgeons by preparing session materials and product or prototype demonstrations, facilitating structured feedback, and documenting actionable clinical insights.
• Collaborate with quality, systems and human factors engineering to conduct preclinical, formative, summative, and validation studies throughout the design process.
• Analyze complaints, field data, and adverse events from a clinical use perspective.
• Support Commercial Education teams in developing and delivering training programs for newly launched products.
• Provide on-site support during initial product commercialization and the escalation of critical performance product complaints.
• Responsible for communicating business-related issues or opportunities to next management level

Qualifications/Requirements:

• Bachelor's degree in Mechanical, Biomedical, Electrical, Robotics Engineering, or a related technical discipline. Master's or PhD preferred, with a focus on medical device development, or related fields.
• Experience with surgical robotics and principles of biomechanics.
• Expertise in design validation, process development, and regulatory compliance.
• Strong problem-solving, analytical reasoning, and decision-making skills.
• Ability to operate independently within a fast-paced, innovative environment.
• Minimum of 7+ years in medical device R&D, with extensive first-hand experience supporting digital technology in the operating theater, early-stage technology incubation, innovative device design, and development.
• Proven track record of contributing clinical and technical expertise to complex projects from concept evaluation through prototype development, initial validation, and initial clinical use.
• Demonstrated ability to lead cross-functional teams and manage projects with minimal supervision.
• Strong entrepreneurial mindset with a focus on disruptive innovation and strategic growth.
• Excellent verbal and written communication skills, with experience presenting to executive leadership, regulatory bodies, and external partners. Proven ability to foster collaborative relationships across internal teams and external research institution.
• This position will require significant interactions with customers of J&J, field sales leaders and external development partners
• Work closely with Health Care Professionals (Surgeons), to conduct preclinical, formative, summative, and validation studies throughout the design process
• Interactions with Health Care Professionals (Surgeons, Clinical Staff) Field Sales, Commercial Education, and Professional Education, administering field based complaint characterization, risk assessments and onsite remediation.
• Collaborate with third-party development partners during prototype development by providing clear clinical specifications, design inputs, and feedback throughout the design process to ensure alignment with clinical, technical, and business requirements.

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.

Required Skills:

Preferred Skills:
Agility Jumps, Analytical Reasoning, Coaching, Collaboration, Critical Thinking, Model-Based Systems Engineering (MBSE), Product Design, Report Writing, Requirements Analysis, Research and Development, SAP Product Lifecycle Management, Scripting Languages, Software Architectures, Software Development Management, Software Engineering Practices, Software Quality Assurance (SQA), Systems Development Lifecycle (SDLC), Technologically Savvy

The anticipated base pay range for this position is :
$109,000.00 - $174,800.00

Additional Description for Pay Transparency:
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)).

This position is eligible to participate in the Company's long-term incentive program.

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 period10 days

Volunteer Leave - 32 hours per calendar year

Military Spouse Time-Off - 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits