Sr Clinical Engineer
Johnson & Johnson
August 14, 2026
On-site
Cincinnati, OH
Operations
Senior Clinical Engineer (OTTAVA Robotic Surgical System) — Cincinnati, Ohio
Performance Objectives And Responsibilities
- Apply clinical, technical, and design control knowledge to discover, define, develop, and validate a new product.
- Partner with physicians and key clinical users to develop/characterize device performance, gather feedback, and integrate insights into iterations.
- Discover unmet clinical needs; establish customer requirements; provide clinical input to engineering design requirements.
- Use clinical knowledge and advanced data analysis to create bench models/metrics to evaluate prototypes and ensure clinical performance needs are met during development.
- Develop clinical workflows; conduct clinical risk assessments; propose mitigations for identified hazards.
- Collaborate with pre-clinical and regulatory teams to support pre-clinical studies.
- Write plans/protocols, conduct formal testing, and report design validation results per FDA regulations.
- Support customer training materials, user manuals, labeling, and formative/summative assessments.
- Support initial product launch and initial cases during customer site bring-up.
Required Qualifications/Skills
- BS in engineering (e.g., Biomedical, Mechanical) + 5 years medical device experience; or MS + 4 years; or PhD + 2 years.
- Experience collaborating with physicians for clinical performance feedback and unmet needs.
- Strong communication/interpersonal skills; cross-functional collaboration (R&D, product management, human factors, professional education).
- Experience designing/conducting pre-clinical engineering studies for performance and safety.
- Ability to identify clinical risks and conduct clinical harm analyses.
- Experience developing Design Validation strategy, protocols, and testing.
- Experience constructing customer and engineering design requirements.
- Ability to make recommendations from technical and clinical inputs.
Preferred
- Advanced degree (Masters/PhD/MD); laparoscopic OR workflow knowledge; surgical robotics basics.
- Prior device/instrument design; MatLab/Python; big data.
- Knowledge of relevant medical device/robotic surgery regulations/standards (FDA, IEC, ISO).
- Proven leadership delivering complex projects.
- Travel up to 15%.
Base pay range: $109,000.00 - $174,800.00.
Performance Objectives And Responsibilities
- Apply clinical, technical, and design control knowledge to discover, define, develop, and validate a new product.
- Partner with physicians and key clinical users to develop/characterize device performance, gather feedback, and integrate insights into iterations.
- Discover unmet clinical needs; establish customer requirements; provide clinical input to engineering design requirements.
- Use clinical knowledge and advanced data analysis to create bench models/metrics to evaluate prototypes and ensure clinical performance needs are met during development.
- Develop clinical workflows; conduct clinical risk assessments; propose mitigations for identified hazards.
- Collaborate with pre-clinical and regulatory teams to support pre-clinical studies.
- Write plans/protocols, conduct formal testing, and report design validation results per FDA regulations.
- Support customer training materials, user manuals, labeling, and formative/summative assessments.
- Support initial product launch and initial cases during customer site bring-up.
Required Qualifications/Skills
- BS in engineering (e.g., Biomedical, Mechanical) + 5 years medical device experience; or MS + 4 years; or PhD + 2 years.
- Experience collaborating with physicians for clinical performance feedback and unmet needs.
- Strong communication/interpersonal skills; cross-functional collaboration (R&D, product management, human factors, professional education).
- Experience designing/conducting pre-clinical engineering studies for performance and safety.
- Ability to identify clinical risks and conduct clinical harm analyses.
- Experience developing Design Validation strategy, protocols, and testing.
- Experience constructing customer and engineering design requirements.
- Ability to make recommendations from technical and clinical inputs.
Preferred
- Advanced degree (Masters/PhD/MD); laparoscopic OR workflow knowledge; surgical robotics basics.
- Prior device/instrument design; MatLab/Python; big data.
- Knowledge of relevant medical device/robotic surgery regulations/standards (FDA, IEC, ISO).
- Proven leadership delivering complex projects.
- Travel up to 15%.
Base pay range: $109,000.00 - $174,800.00.