Staff Systems Eng, Navigation

Johnson & Johnson MedTech; Warsaw (IN); On-site; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson in the United States is seeking a Staff Systems Engineer for the Navigation R&D team, based in Warsaw, IN and Boston, MA. You will generate system requirements, perform risk analysis, and collaborate with cross-disciplinary teams across hardware, software, and marketing to advance orthopedic robotic platforms.

Responsibilities include implementing design controls, managing ALM workflows, and supporting regulatory submissions while ensuring IEC 60601 and ISO 14971 alignment.

Qualifications

• 8+ years of systems engineering experience.
• BS in Systems Engineering, Biomedical Engineering, Robotics, or Mechatronics.
• Advanced/Graduate degree preferred.
• Experience with orthopedic medical device product development.
• Experience with surgical navigation or robotics.
• Experience with Design Controls and requirements management in a medical device development environment.
• Experience in ALM systems such as Polarion.
• Experience with sustaining engineering and change management of medical devices.
• Experience executing system design verification and validation testing.
• Knowledge of IEC 60601, ISO 14971, ISO 13485 and 62366.
• Experience in an operating room setting supporting surgeons in the use of digital technology.

Responsibilities

• Perform requirements management, ensuring requirements are structured, organized, maintained, and communicated across multi-disciplined and multi-site teams.
• Be responsible for performing system level risk analysis, including use risk analysis, in a highly regulated environment.
• Collaborate with sub system teams on requirements and risk cascade.
• Collaborate with cross-disciplinary teams developing design strategies, system architectures, functional diagrams and participate in the generation of concepts.
• Evaluate multi-functional solutions to help identify and select the best design answers for specific requirements.
• Partner with key partners to develop use cases and user stories to further define system user needs, design requirements and system risks.
• Provide continuing systems engineering support to existing products and sustaining engineering activities.
• Analyze mechanical, electrical, and software interfaces. Work with cross functional teams on system integration and interface management, ensuring high system performance and reliability.
• Partner with hardware engineering, electrical engineering, software engineering, marketing, and testing using a systems engineering approach throughout the product development lifecycle.
• Support regulatory submissions.
• Ensure system requirements, designs and deliverables meet Medical Device Electrical Safety (IEC 60601) Requirements.
• Coach team members on System Engineering methodologies and best practices.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

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

R&D Software/Systems Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Boston, Massachusetts, United States of America, Warsaw, Indiana, United States of America

Job Description

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for a Staff Systems Engineer, located in Warsaw, IN and Boston, MA.

Purpose

As s Staff Systems Engineer in the Navigation R&D team, this position will play an important role in the forefront of digital and robotic technology for the orthopedic medical device industry. You will be responsible for system requirements generation and performing risk analysis for orthopedic robotic platforms among other system engineering tasks including sub-system integration. Additionally, you will work with cross-disciplinary teams to update and maintain system architectures, user interfaces and instructions for use as well as support subsystem coordination. Communication and collaboration with cross-disciplinary teams will be essential for success.

Job Responsibilities

• Perform requirements management, ensuring requirements are structured, organized, maintained, and communicated across multi-disciplined and multi-site teams.
• Be responsible for performing system level risk analysis, including use risk analysis, in a highly regulated environment.
• Collaborate with sub system teams on requirements and risk cascade.
• Collaborate with cross-disciplinary teams developing design strategies, system architectures, functional diagrams and participate in the generation of concepts.
• Evaluate multi-functional solutions to help identify and select the best design answers for specific requirements.
• Partner with key partners to develop use cases and user stories to further define system user needs, design requirements and system risks.
• Provide continuing systems engineering support to existing products and sustaining engineering activities.
• Analyze mechanical, electrical, and software interfaces. Work with cross functional teams on system integration and interface management, ensuring high system performance and reliability.
• Partner with hardware engineering, electrical engineering, software engineering, marketing, and testing using a systems engineering approach throughout the product development lifecycle.
• Support regulatory submissions.
• Ensure system requirements, designs and deliverables meet Medical Device Electrical Safety (IEC 60601) Requirements.
• Coach team members on System Engineering methodologies and best practices.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Required Qualifications – Experience & Education

• 8+ years of experience of relevant systems engineering
• BS in Systems, Biomedical Engineering, Robotics, or Mechatronics.
• Advanced/Graduate degree in engineering preferred.
• Degree or experience in systems engineering.
• Experience with orthopedic medical device product development.
• Experience with surgical navigation or robotics.
• Experience with Design Controls and requirements management in a medical device development environment.
• Experience in ALM (Application Lifecycle Management) system such as Polarion
• Experience with sustaining engineering and change management of medical devices.
• Experience executing system design verification and validation testing.
• Knowledge of standards including IEC 60601, ISO 14971, ISO 13485 and 62366.
• Experience in an operating room setting supporting surgeons in the use of digital technology.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

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 & Jonnson 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, Coaching, Model-Based Systems Engineering (MBSE), Process Oriented, Product Design, Requirements Analysis, Research and Development, SAP Product Lifecycle Management, Scripting Languages, Software Development Life Cycle (SDLC), Software Development Management, Software Engineering Practices, Software Testing, Systems Development Lifecycle (SDLC), Technical Credibility, Technologically Savvy

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

Additional Description For Pay Transparency

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.

Benefits

Subject to the terms of their respective policies and date of hire, 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 Colorado –48 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
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits