Sr Clinical Engineer

6267-Auris Health Inc. Legal Entity; Cincinnati (OH); On-site; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson MedTech is seeking a Senior Clinical Engineer for the OTTAVA Robotic Surgical System team in Cincinnati, Ohio. You will lead cross-functional efforts to define clinical requirements, design inputs, and validate performance with physicians and engineers.

You will develop bench models, conduct risk analyses, and support preclinical studies and initial launches, while collaborating across regulatory, clinical, and product teams in a fast-paced medical device environment.

Qualifications

• Bachelor's degree in engineering (Biomedical/Mechanical) with 5+ years in medical devices.
• Experience collaborating with physicians to gather clinical performance feedback.
• Strong communication and interpersonal skills for cross-functional collaboration.
• Experience designing preclinical engineering studies to assess product performance and safety.
• Knowledge of regulatory standards for medical devices and robotics.

Responsibilities

• Develop and validate clinical workflows and risk assessments for new devices.
• Partner with physicians to define user needs and clinical requirements.
• Write plans, protocols, and conduct testing to FDA- required validation.
• Support product launches and customer training at initial sites.
• Collaborate with regulatory, preclinical, and engineering teams throughout development.

Skills

Strong communication

Cross-functional collaboration

Clinical requirements analysis

Problem solving

Leadership of complex projects

Travel up to 15%

Education

Bachelor's degree in engineering (Biomedical/Mechanical)

Master's degree or PhD preferred

Tools

MATLAB

Python

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.com

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

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 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 technique to develop bench models and metrics for evaluation of prototypes designs to ensure 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 preclinical and regulatory teams to support and advance preclinical studies Write plans, protocols, conduct formal testing, and report results of Design validation studies throughout the design process as required by FDA regulations Support developing customer training materials, user manuals, labeling, formative and summative assessments Support 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 needs
• Strong 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 preclinical 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
• Preferred Advanced degree (Masters, PhD, MD)
• Knowledge of laparoscopic procedures and operating room workflow
• Familiar with fundamental concepts in surgical robotics
• Prior device or instrument design experiences
• Proficient in statistical methods and programming languages such as MatLab, Python is a plus 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.
• Have the ability to travel up to 15% of the time, internationally and domestic

Preferred Skills

• Bioinformatics, Biological Engineering, Biostatistics, Coaching, Critical Thinking, Design of Experiments (DOE), Healthcare Trends, Industry Analysis, Innovation, Medicines and Device Development and Regulation, Product Development, Relationship Building, Research and Development, Researching, SAP Product Lifecycle Management, Standard Scientific Processes and Procedures, Technologically Savvy

Additional Information

The anticipated base pay range for this position is : $109,000.00 - $174,800.00 Additional Description for Pay Transparency: At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/.

Johnson & 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.