Staff Systems Eng, Navigation
Johnson & Johnson
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Benefits offered by this job
Job summary
Johnson & Johnson in Boston, MA and Warsaw, IN seeks a Staff Systems Engineer to lead system requirements, risk analysis, and cross‑functional integration for orthopedic robotic platforms. You will guide designs from concept to validation, collaborate with hardware, software and marketing teams, and support regulatory submissions in a highly regulated environment.
The role emphasizes model-based systems engineering, design controls, and sustaining engineering with a focus on improving patient
Qualifications
- 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 system 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 across multi-site teams.
- Conduct system level risk analysis in a regulated environment.
- Collaborate with subsystem teams on requirements and risk cascade.
- Develop design strategies, system architectures and functional diagrams.
- Evaluate multi-functional solutions to identify best design answers.
- Develop use cases and user stories with partners.
- Provide ongoing systems engineering support to existing products.
- Analyze interfaces and ensure high system performance and reliability.
- Work with hardware, electrical and software teams across product lifecycle.
- Support regulatory submissions and IEC 60601 compliance.
- Coach team members on systems engineering methodologies.
- Ensure compliance with health, safety and environmental practices.
Skills
Education
Tools
Job description
R&D Product Development
R&D Software/Systems Engineering
Scientific/Technology
Boston, Massachusetts, United States of America, Warsaw, Indiana, United States of America
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.
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.
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:
- 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.
- 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 & 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.
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
$109,000.00 - $174,800.00
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.
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
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