R&D Systems Engineer

Johnson & Johnson Innovative Medicine•Boston, MA

3d•$78,000 - $126,500•Hybrid

About The Position

Johnson & Johnson is seeking a Systems Engineer for its Orthopaedics business, based in Boston, Massachusetts, with an expectation to work in the office at least three days per week. The role supports the development of digital and robotic technologies for orthopaedic medical devices, with a focus on system requirements generation and risk analysis for orthopaedic robotic platforms. The engineer will collaborate with cross-disciplinary teams to develop requirements, manage risks, review and update system architectures, and coordinate subsystems in a highly regulated environment. The position contributes throughout the system lifecycle, from defining user needs and system concepts through implementation, integration, verification, validation, usability activities, and product launch. It also supports requirements traceability, change impact assessments, regulatory submissions, system workflow and usability improvements, and analysis of system safety and effectiveness. The role requires clear communication of technical material to stakeholders and users at all levels.

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 orthopaedic 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 standards including IEC 60601, ISO 14971, ISO 13485, and 62366.
Experience in an operating room setting supporting surgeons in the use of digital technology.

Nice To Haves

Advanced or graduate degree in engineering.
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.
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 that define 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 activities, including evaluation and troubleshooting of interactions across hardware, software, and subsystems.
Participate in system verification, validation, and usability activities, including protocol development, test execution, analysis, and documentation of results.
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

Participation in the Company’s consolidated retirement plan (pension), subject to plan terms.
Participation in the Company’s savings plan (401(k)), subject to plan terms.
Eligibility to participate in the Company’s long-term incentive program.
Vacation: 120 hours per calendar year, subject to policy and date of hire.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington, subject to policy and date of hire.
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: 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.