R&D Systems Engineer

Johnson & Johnson•Boston, MA

1d•Hybrid

About The Position

Johnson & Johnson is seeking a Systems Engineer for its Orthopaedics business, based in Boston, Massachusetts, with an expectation of working in the office at least three days per week. The role contributes to the development of digital and robotic technology for orthopedic medical devices, including generating system requirements and conducting risk analysis for orthopedic robotic platforms. The engineer works with cross-disciplinary teams to develop requirements, manage risks, review and update system architectures, and coordinate subsystems across the system lifecycle. The position supports system development, integration, verification, validation, usability, and product launch in a highly regulated environment. It also contributes to requirements traceability, regulatory submissions, system workflows, and technical communications for stakeholders and users. Johnson & Johnson announced plans to separate its Orthopaedics business into a standalone company operating as DePuy Synthes; completion is anticipated within 18 to 24 months, subject to applicable requirements and approvals.

Requirements

1–2 years of experience in a medical device new product development environment.
Bachelor of Science in Systems, Biomedical Engineering, Robotics, or Mechatronics.
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 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 standards.
Experience in an operating room setting supporting surgeons in the use of digital technology.

Nice To Haves

Advanced or graduate degree in engineering is preferred.
Preferred skills include analytical reasoning, business behavior, execution focus, Model-Based Systems Engineering (MBSE), problem solving, process orientation, 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 writing, and technological savvy.

Responsibilities

Perform system-level risk management activities, including use-related risk analysis, in a highly regulated environment.
Collaborate with subsystem teams on requirements and risk decomposition and cascade.
Work with cross-disciplinary teams to develop design strategies, system architectures, functional diagrams, and system concepts.
Participate in system development, implementation, and integration to support verification, validation, and product launch.
Identify, evaluate, and communicate system requirements and risks with design teams throughout the system lifecycle.
Partner with cross-functional stakeholders to develop use cases and user stories defining user needs, design requirements, and system risks.
Support requirements traceability and change impact assessments across user needs, system requirements, subsystem requirements, and risk controls.
Participate in system integration, including evaluating and troubleshooting interactions across hardware, software, and subsystems.
Participate in system verification, validation, and usability activities, including protocol development, test execution, analysis, and results documentation.
Support development and improvement of system workflows, usability, and instructions for use.
Support regulatory submissions.
Perform analyses to evaluate and support the safety and effectiveness of the system architecture.
Generate and present technical material for stakeholders and users at all levels.

Benefits

Consolidated retirement plan (pension), subject to plan terms.
401(k) savings plan, subject to plan terms.
Eligibility to participate in the long-term incentive program.
Vacation: 120 hours per calendar year, subject to policy and hire-date terms.
Sick time: 40 hours per calendar year, with specified state-based amounts for Colorado and Washington employees.
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, or foster care of a child.
Bereavement Leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.