Staff Clinical Engineer

Johnson & Johnson • Boston, MA

11d • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Robotics Engineering, or a related technical discipline.
• 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.

Nice To Haves

• Master’s or PhD preferred, with a focus on medical device development, or related fields.

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior