Sr. Clinical Engineer

Biopharma Careers; Cincinnati (OH); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Travel up to 15%

Job summary

Johnson & Johnson in Cincinnati seeks a Senior Clinical Engineer to lead clinical input for the OTTAVA Robotic Surgical System. You will collaborate with physicians to define device performance, assess risks, and guide product development through FDA-aligned validation and pre-clinical activities.

The role requires a strong engineering background (Bachelor's plus 5+ years in medical devices), cross-functional leadership, and effective communication to ensure patient safety and regulatory

Qualifications

• Bachelor's degree in engineering with 5+ years in medical device industry.
• Experience collaborating with physicians to gather clinical performance feedback.
• Experience designing and conducting pre-clinical engineering studies.

Responsibilities

• Apply clinical, technical, and design control knowledge to collaborate with a cross-functional team to discover, define, develop, and validate a new product.
• Partner with physicians and clinical users to develop device performance and gather feedback.
• Develop bench models and metrics to evaluate prototype designs for clinical performance.
• Create and execute Design Validation plans, protocols, and testing as per FDA requirements.
• Support pre-clinical studies and initial product launch activities.

Skills

Clinical knowledge

Cross-functional collaboration

Regulatory risk analyses

Design Validation

Data analysis

Programming (MATLAB)

Programming (Python)

Education

Bachelor's degree in Engineering

Advanced degree preferred (MS/PhD/MD)

Tools

MATLAB

Python

Job description

## About this opportunityAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.comAs guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.**Job Function:**R&D Product Development**Job Sub Function:**Biomedical Engineering**Job Category:**Scientific/Technology**All Job Posting Locations:**Cincinnati, Ohio, United States of America**Job Description:****About MedTech**Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech**Senior Clinical Engineer**Robotics and Digital Solutions, part of Johnson & Johnson MedTech family of companies, is recruiting for a Senior Clinical Engineer for the OTTAVA Robotic Surgical System team. This position is located in Cincinnati, Ohio.**What We Do:**The Ottava team envisions a future for robotic intervention that is targeted, minimally invasive, and personalized. Building upon a deep understanding of patient and physician needs, we are developing a platform for the next evolution of soft-tissue robotic care!**Who We Are:**We are a team of clinical, electrical, mechanical, mechatronics, robotic controls, and software engineers who are passionate about improving patient care. The team includes a wide range of experience levels from junior engineers to industry experts. We value autonomy and empower each other to take action while remaining a supportive and closely knit team. We take pride in our culture and are committed to building an environment that is inclusive and promotes diversity of thought through varied experiences and backgrounds.**You:**As a member of the Clinical Engineering team, you will join us on our journey to design and build a First-Of-Its-Kind Table-Integrated Robotic System. With a unique architecture, clinically differentiated instruments, and backed by an open digital ecosystem, we are looking for a high impact, user-centric clinical engineer to join our team to expand our instrument portfolio. You will have the opportunity to understand user needs, establish clinical and engineering requirements and design inputs, consider clinical risks, solve technical problems in clinical settings and identify solutions to guide product development. This role offers high autonomy and growth opportunities within the team as we progress towards realizing our vision. If you enjoy being in the forefront of product development working alongside with clinicians and engineers, we love to hear from you.**Performance Objectives and Responsibilities:**Apply in-depth clinical, technical, and design control knowledge to collaborate with a cross-functional team to discover, define, develop, and validate a new productPartner with physicians and key clinical users to develop and characterize device performance, gather product feedback, and integrate their insights into product iterationsDiscover unmet clinical needs, establish customer requirements and provide clinical input to engineering design requirementsApply clinical knowledge and advanced data analysis technique to develop bench models and metrics for evaluation of prototypes designs to ensure clinical performance needs are met and maintained during developmentDevelop new product clinical workflows, conduct clinical risk assessments, and propose effective mitigations for identified hazardsCollaborate with pre-clinical and regulatory teams to support and advance pre-clinical studiesWrite plans, protocols, conduct formal testing, and report results of Design validation studies throughout the design process as required by FDA regulationsSupport developing customer training materials, user manuals, labeling, formative and summative assessmentsSupport initial product launch and initial cases during customer site bring up**Required Experience and Skills**Hold a bachelor's degree in engineering (e.g. Biomedical, Mechanical) with a minimum of 5 years of related work experience in medical device industry (Master’s + 4 years of experience or PhD + 2 years of experience)Experience collaborating with physicians to gather clinical performance feedback and identify unmet needsStrong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams such as R&D, product management, human factors, professional education etc.Experience designing and conducting pre-clinical engineering studies to assess product performance and safetyProficient in identifying potential clinical risks and conducting thorough clinical harm analyses to enhance patient safety and product reliabilityExperience developing Design Validation strategy, protocol creation and testingExperience constructing customer and engineering design requirementsAbility to draw conclusions and make recommendations based on technical and clinical inputs from multiple and varied sources**Preferred**Advanced degree (Masters, PhD, MD)Knowledge of laparoscopic procedures and operating room workflowFamiliar with fundamental concepts in surgical roboticsPrior device or instrument design experiencesProficient in statistical methods and programming languages such as MatLab, Python is a plusBig dataStrong knowledge of relevant regulations and standards for medical devices and robotic surgery platforms, including FDA regulations and guidance, and IEC and ISO standards.Demonstrated success in leading and delivering complex projects from inception to completion.Have the ability to travel up to 15% of the time, internationally and domesticJohnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.**Required Skills:****Preferred Skills:**Analytical Reasoning, Bioinformatics, Biological Engineering, Biological Sciences, Biostatistics, Coaching, Data Savvy, Detail-Oriented, Feasibility Studies, Inventory Management, Preclinical Research, Project Schedule, Prototyping, Research and Development, Researching, SAP Product Lifecycle Management, Technologically Savvy