Sr Clinical Engineer

At 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.

About the role

As a Senior Clinical Engineer on the OTTAVA Robotic Surgical System team, part of Johnson & Johnson MedTech, you will join us in Cincinnati, Ohio, to design and build a first-of-its-kind table-integrated robotic system. This role focuses on expanding our instrument portfolio by understanding user needs, establishing clinical and engineering requirements, assessing clinical risks, and guiding product development. You will collaborate closely with clinicians and engineers, offering high autonomy and growth opportunities as we work toward realizing our vision.

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.

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 multidisciplinary team of clinical, electrical, mechanical, mechatronics, robotic controls, and software engineers passionate about improving patient care. Our team includes a wide range of experience levels, from junior engineers to industry experts. We value autonomy, collaboration, and diversity of thought, fostering an inclusive environment that promotes varied experiences and backgrounds.

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 product.
• Partner with physicians and key clinical users to develop and characterize device performance, gather product feedback, and integrate their insights into product iterations.
• Discover unmet clinical needs, establish customer requirements, and provide clinical input to engineering design requirements.
• Apply clinical knowledge and advanced data analysis techniques to develop bench models and metrics for evaluating prototype designs, ensuring clinical performance needs are met and maintained during development.
• Develop new product clinical workflows, conduct clinical risk assessments, and propose effective mitigations for identified hazards.
• Collaborate with pre-clinical and regulatory teams to support and advance pre-clinical studies.
• Write plans, protocols, conduct formal testing, and report results of Design Validation studies throughout the design process as required by FDA regulations.
• Support the development of customer training materials, user manuals, labeling, formative and summative assessments.
• Support initial product launch and initial cases during customer site bring-up.

Requirements

• Hold a bachelor's degree in engineering (e.g., Biomedical, Mechanical) with a minimum of 5 years of related work experience in the medical device industry. (Master’s + 4 years of experience or PhD + 2 years of experience also qualifies.)
• Experience collaborating with physicians to gather clinical performance feedback and identify unmet needs.
• Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams such as R&D, product management, human factors, and professional education.
• Experience designing and conducting pre-clinical engineering studies to assess product performance and safety.
• Proficient in identifying potential clinical risks and conducting thorough clinical harm analyses to enhance patient safety and product reliability.
• Experience developing Design Validation strategy, protocol creation, and testing.
• Experience constructing customer and engineering design requirements.
• Ability to draw conclusions and make recommendations based on technical and clinical inputs from multiple and varied sources.
• Ability to travel up to 15% of the time, internationally and domestically.

Preferred Qualifications

• Advanced degree (Masters, PhD, MD).
• Knowledge of laparoscopic procedures and operating room workflow.
• Familiarity with fundamental concepts in surgical robotics.
• Prior device or instrument design experience.
• Proficiency in statistical methods and programming languages such as MATLAB or Python.
• Experience with big data.
• Strong 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.

Pay

The anticipated base pay range for this position is $109,000.00 - $174,800.00.