Sr. Clinical Engineer

6267-Auris Health Inc. Legal Entity; Cincinnati (OH); On-site; USD 92,000 - 148,000; Full time

Job summary

Johnson & Johnson, a leader in MedTech, seeks a Senior Clinical Engineer for the OTTAVA Robotic Surgical System in Cincinnati. You will translate clinical needs into engineering requirements and work with clinicians to shape a first-of-its-kind robotic platform.

You will lead design validation efforts, perform risk analyses, and collaborate across R&D, regulatory, and pre-clinical teams to ensure safe, effective patient care with high autonomy and growth opportunities.

Qualifications

• Bachelor's degree in Engineering with 5+ years of medical device experience
• Experience collaborating with physicians to gather clinical feedback
• Strong communication and interpersonal skills across R&D, PM, HF, education teams
• Experience designing pre-clinical studies to assess product performance and safety
• Ability to identify clinical risks and perform clinical harm analyses
• Experience creating Design Validation strategies, protocols and testing

Responsibilities

• Apply clinical, technical, and design control knowledge to define and validate a new product
• Partner with physicians to gather feedback and iteratively improve device performance
• Identify unmet clinical needs and translate into engineering requirements
• Develop bench models and metrics to evaluate prototype designs for clinical performance
• Create and assess clinical workflows and conduct risk mitigations
• Collaborate with pre-clinical and regulatory teams on studies
• Write plans, protocols, and reports for Design Validation activities
• Support customer training materials and initial launches

Skills

Cross-functional collaboration

Communication skills

Clinical engineering interface

Pre-clinical studies

Design validation planning

Education

Bachelor's degree in Engineering

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 As 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 product
• Partner with physicians and key clinical users to develop and characterise 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 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 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 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

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

The anticipated base pay range for this position is :

The anticipated base pay range for this position is : $92,000.00 - $148,350.00 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/. Do Not Sell or Share My Personal Information Limit the Use of My Personal Information