Senior Clinical Engineer, Robotic MedTech Innovation

Johnson & Johnson; Cincinnati (OH); On-site; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson in Cincinnati is seeking a Senior Clinical Engineer for the OTTAVA Robotic Surgical System team. You will join a cross-disciplinary team of clinical, electrical, mechanical, mechatronics, and software engineers to advance a table-integrated robotic platform.

The role emphasizes clinical risk management, design validation, and collaboration with physicians to translate clinical needs into robust device performance.

Qualifications

• Bachelor's degree in engineering (Biomedical or Mechanical) with 5+ years in medical device.
• Experience collaborating with physicians to gather clinical performance feedback.
• Strong communication and cross-functional collaboration.
• Experience designing pre-clinical engineering studies to assess product performance and safety.
• Proficient in identifying potential clinical risks and conducting thorough clinical harm analyses.
• Knowledge of FDA regulations and ISO standards for medical devices.
• Willingness to travel up to 15% (international and domestic).

Responsibilities

• Apply clinical, technical, and design control knowledge to develop a new product.
• Partner with physicians to develop device performance, gather feedback, and iterate.
• Discover unmet clinical needs, establish customer requirements and translate into design inputs.
• Develop bench models and metrics to evaluate prototype designs for clinical performance.
• Conduct clinical risk assessments and propose mitigations for identified hazards.
• Collaborate with pre-clinical and regulatory teams to support studies.
• Write plans, protocols, and reports for Design Validation studies per FDA requirements.
• Support customer training materials, user manuals, labeling, and assessments.
• Support initial product launch and early customer site bring-up.

Skills

Cross-functional collaboration

Communication

Clinical risk analysis

Design validation

Statistical methods

Programming (MATLAB/Python)

Education

Bachelor's degree in engineering (Biomedical/Mechanical)

Advanced degree (MS/PhD/MD)

Job description

Johnson & Johnson in Cincinnati is seeking a Senior Clinical Engineer for the OTTAVA Robotic Surgical System team. You will join a cross-disciplinary team of clinical, electrical, mechanical, mechatronics, and software engineers to advance a table-integrated robotic platform.

The role emphasizes clinical risk management, design validation, and collaboration with physicians to translate clinical needs into robust device performance.