Sr Systems Engineer – Nav R&D

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

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 hiring a Senior Systems Engineer – Navigation R&D for a hybrid role based in Boston, MA or Warsaw, IN. The role requires up to 10% domestic and/or international travel.

As a Senior Systems Engineer on the Navigation R&D team, you will help develop next-generation surgical navigation systems for orthopaedics. You will own system requirements, risk analysis and interface definitions for assigned features and subsystems, and keep them clear, traceable and testable from user needs through verification and validation. You will work closely with software, hardware, human factors, V&V, quality and regulatory partners to deliver safe, reliable systems for surgeons.

• →Author, decompose and maintain system and subsystem requirements for assigned features. Keep them structured, traceable and communicated across multi-site teams.
• →Perform system-level risk analysis, including hazard analysis, use risk analysis and FMEA, for assigned areas. Support risk cascade to subsystem teams.
• →Work with software, hardware and V&V teams to make sure requirements are testable and fully traced from user needs through verification and validation.
• →Develop use cases, user stories and workflows with clinical, marketing and human factors partners to define user needs and design inputs.
• →Define and analyze mechanical, electrical and software interfaces. Support system integration, integration testing and issue resolution.
• →Contribute to system architecture, functional diagrams and design trade-off studies under the guidance of Staff/Principal engineers.
• →Support design reviews, change impact assessments and sustaining engineering for released products.
• →Support regulatory submissions and DHF deliverables. Make sure system deliverables meet IEC 60601, ISO 14971 and IEC 62366 requirements.
• →Engage with surgeons and clinical staff, including in lab and OR settings, to clarify user needs and evaluate system performance.
• →Mentor junior engineers and co-ops on systems engineering methods and tools.
• →Communicate business-related issues or opportunities to the next management level.
• →Follow all Company guidelines on Health, Safety and Environmental practices, and ensure personal and Company compliance with all applicable regulations, policies and procedures.

• Bachelor's degree in Systems, Biomedical, Electrical, Mechanical, Robotics or Mechatronics Engineering, or a related field.
• 5+ years of relevant systems engineering experience in medical devices or another regulated industry.
• Experience with Design Controls, requirements management and risk management in a regulated environment.
• Experience with an ALM/requirements tool such as Polarion, Jama or DOORS.
• Working knowledge of IEC 60601, ISO 14971, ISO 13485 and IEC 62366.
• Experience with system integration and interface management across software, electrical and mechanical subsystems.
• Strong technical writing, communication and cross-functional collaboration skills.

• Advanced/graduate degree in engineering.
• Experience with surgical navigation, robotics or image-guided surgery systems.
• Experience developing orthopaedic medical devices.
• Experience supporting system design verification and validation testing.
• Experience with sustaining engineering and change management for released medical devices.
• Experience in an operating room setting supporting surgeons who use digital technology.
• Familiarity with MBSE/SysML or AI-assisted engineering tools.

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