Senior Clinical Engineer

6267-Auris Health Inc. Legal Entity; Santa Clara (CA); On-site; USD 125,000 - 201,000; Full time

Benefits offered by this job

Vacation – 120 hours per calendar year

Sick time – 40 hours per calendar year

Holiday pay – 13 days per calendaryear

Parental Leave – 480 hours within one

Company benefits (medical, dental, 401

Job summary

Johnson & Johnson MedTech is recruiting a Senior Clinical Engineer for the OTTAVA Robotic Surgical System team in Santa Clara, CA. You will design and build a first-of-its-kind table-integrated robotic platform, translating clinical needs into engineering requirements and ensuring regulatory alignment throughout development.

You will work with a multidisciplinary team of clinicians and engineers, applying risk analysis, design validation strategies, and hands-on clinical input to advance product

Qualifications

• Bachelor's degree in engineering with a minimum of 5 years in medical devices.
• Experience collaborating with physicians to gather feedback and needs.
• Strong communication and cross-functional collaboration skills.
• Experience designing pre-clinical studies to assess performance and safety.
• Ability to identify clinical risks and conduct thorough harm analyses.

Responsibilities

• Apply clinical, technical, and design control knowledge to define, develop, and validate a new product.
• Partner with physicians to characterize system performance and gather feedback for iterations.
• Translate unmet clinical needs into customer requirements and engineering inputs.
• Develop clinical risk assessments and mitigation strategies for identified hazards.
• Support pre-clinical studies and FDA-regulatory alignment throughout development.

Skills

Clinical engineering

Medical devices

Cross-functional collaboration

Design validation

Regulatory awareness

Education

Bachelor's degree in engineering

Advanced degree preferred

Job description

Job Function: R&D Product Development

Job Sub Function: Biomedical Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Santa Clara, California, United States of America

Job Description

Johnson & Johnson MedTech is recruiting for a Senior Clinical Engineer for the OTTAVA Robotic Surgical System team. This position is located in Santa Clara, CA.

About MedTech

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 procedure capability. You will have the opportunity to deeply immerse in the development of the clinical application with the Ottava system. You will develop understanding of the surgical practices in different specialities and translate that to 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, and validation and regulatory strategy. This role offers high autonomy and growth opportunities within the team as we progress towards realizing our vision.

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 system 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 benchmark system performance against current practice in tissue models
• Develop bench models and metrics for evaluation 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

• Advanced degree (Masters, PhD, MD)
• Knowledge of endoscopic, laparoscopic procedures and operating room workflow
• Familiar with fundamental concepts in surgical robotics
• 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 with an emphasis on usability from inception to completion.
• Have the ability to travel up to 15% of the time, internationally and domestic

Compensation and Benefits

The anticipated base pay range for this position is : $125,000.00 - $201,250.00

Additional Description for Pay Transparency

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave – 10 days
• Volunteer Leave – 4 days
• Military Spouse Time-Off – 80 hours

Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

EEO Statement

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. 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.

Company Culture

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/.

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