About Orthopaedics
Fueled by innovation at the intersection of biology and technology, Johnson & Johnson's Orthopaedics teams are developing the next generation of smarter, less invasive, more personalized treatments. The Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems, building solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.
We are searching for a System Engineer to be based out of Boston, Massachusetts, USA with in-office expectations of a minimum of 3 days per week.
Purpose
This position will play a key role at the forefront of digital and robotic technology for the orthopedic medical device industry. You will participate in system requirements generation and risk analysis for orthopedic robotic platforms. As a Systems Engineer you will work with cross-disciplinary teams to develop system requirements, perform risk management, review and update system architectures, and support subsystem coordination. Communication and collaboration with cross-disciplinary teams will be essential for success.
Job 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.
•Collaborate with cross-disciplinary teams in developing design strategies, system architectures, functional diagrams, and system concepts.
•Participate in system development, implementation, and integration to support successful verification, validation, and product launch.
•Identify, evaluate, and communicate system requirements and risks in concert with design teams throughout the system lifecycle.
•Partner with cross-functional stakeholders to develop use cases and user stories that further define system 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 appropriate analyses to evaluate and support the safety and effectiveness of the system architecture.
•Generate and present technical material necessary for the understanding of stakeholders and users at all levels.
Qualifications/Requirements
•1-2 years of experience in a medical device new product development environment.
•BS in Systems, Biomedical Engineering, Robotics, or Mechatronics.
•Advanced/Graduate degree in engineering 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 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.
Preferred Skills
Analytical Reasoning, Business Behavior, Execution Focus, Model-Based Systems Engineering (MBSE), Problem Solving, 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 Writing, Technologically Savvy.
Note
Johnson & Johnson announced plans to separate its 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.
Compensation
The anticipated base pay range for this position is $78,000.00 - $126,500.00.
Additional benefits: employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)), and 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 period
•Volunteer Leave – 32 hours per calendar year
•Military Spouse Time-Off – 80 hours per calendar year
