Staff Clinical Engineer

Johnson & Johnson•Boston, MA

11d•Hybrid

About The Position

The Staff Clinical Engineer works closely with product development teams and clinicians to advance early-stage ideas into clinically relevant devices and features for orthopaedic surgical robotics and navigation. The role provides clinical and technical expertise to define user needs, clinical requirements, and real-world performance considerations, with the goal of delivering safe, effective, differentiated solutions and improving patient outcomes. The position supports technology transfer from concept to clinical application and partners with cross-functional teams, external research institutions, and industry partners. It contributes clinical and scientific expertise throughout the product lifecycle, including prototype development, validation, initial clinical use, commercialization, and post-commercial performance review. The role is based in Boston or Raynham, Massachusetts, and requires working in the office at least three days per week.

Requirements

Bachelor’s degree in Mechanical, Biomedical, Electrical, or Robotics Engineering, or a related technical discipline.
At least 7 years of medical device R&D experience, including 2–3 years of hands-on experience in the orthopaedic space.
Hands-on experience in one or more of the following: supporting technology in the operating room, early-stage innovation, or device design and development.
Solid understanding of orthopaedic anatomy, surgical techniques, instrumentation, and implant workflows.
Working knowledge of orthopaedic procedures such as hip, knee, and shoulder arthroplasty and operating room workflows, gained through direct clinical exposure and collaboration with surgeons and clinical staff.
Experience with surgical robotics or computer-assisted surgery and principles of biomechanics.
Experience contributing clinical and technical expertise to complex projects from concept evaluation through prototype development, initial validation, and initial clinical use.
Ability to lead cross-functional teams and manage projects with minimal supervision.
Strong problem-solving, analytical reasoning, and decision-making skills.
Ability to work independently in a fast-paced, innovative environment.
Strong entrepreneurial mindset focused on disruptive innovation and strategic growth.
Excellent verbal and written communication skills, including experience presenting to executive leadership, regulatory bodies, and external partners.
Ability to foster collaborative relationships across internal teams and external research institutions.
Ability to interact significantly with J&J customers, field sales leaders, and external development partners.

Nice To Haves

Master’s or PhD, preferably focused on medical device development or a related field.

Responsibilities

Contribute clinical and technical expertise to ideation, conceptualization, and early-stage evaluation of novel design concepts.
Support feasibility assessments and prototype development, ensuring alignment with clinical needs and applicable regulatory pathways.
Prepare and deliver 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 quantitative clinical and operational needs to increase innovation value.
Lead the creation of clinical hazard analyses and procedure-specific risk maps to inform project scope and timelines.
Evaluate trends in computer-assisted orthopaedic surgery, surgical robotics, navigated devices, and emerging surgical techniques; translate insights into project goals and prototype development input.
Identify critical tasks, potential use errors, and hazardous situations in clinical contexts.
Collaborate with systems engineering to develop test methods, models, and metrics that 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, inefficiencies, and complications.
Gather Voice of the Clinician insights, identify unmet clinical needs, and translate them into system-level opportunities and requirements.
Support Voice of Customer sessions with surgeons by preparing materials and demonstrations, facilitating structured feedback, and documenting actionable insights.
Collaborate with quality, systems, and human factors engineering on 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 for newly launched products.
Provide on-site support during initial product commercialization and escalation of critical product-performance complaints.
Communicate business-related issues and opportunities to the next management level.
Work with health care professionals, including surgeons and clinical staff, and interact with field sales, Commercial Education, and Professional Education on studies, complaint characterization, risk assessments, and on-site remediation.
Collaborate with third-party development partners by providing clinical specifications, design inputs, and feedback throughout prototype development.

Benefits

Participation in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the Company’s long-term incentive program.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington.
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 a child’s birth, adoption, or foster-care placement.
Bereavement leave: 240 hours for an immediate family member and 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.