Staff R&D Systems Engineer

Johnson & Johnson•Boston, MA

1d•Onsite

About The Position

Johnson & Johnson is seeking a Staff R&D Systems Engineer for its Orthopaedics business, based in Boston, Massachusetts. The role contributes to the development of digital and robotic technology for orthopedic medical devices, with responsibility for system requirements, system-level and use risk analysis, subsystem integration, and coordination across multidisciplinary teams. The engineer will help maintain system architectures, user interfaces, and instructions for use, and provide systems engineering support throughout product development and for existing products.

Requirements

Bachelor’s degree in Systems, Biomedical Engineering, Robotics, or Mechatronics.
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 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 preferred.
Preferred skills include computer programming, cost-benefit analysis, critical thinking, data science, industry analysis, innovation, manufacturing technologies, organizing, problem solving, process improvements, prototyping, quality assurance, quality control, research and development, robotic automation, SAP Product Lifecycle Management, and technical credibility.
Additional listed skills include agility jumps, analytical reasoning, coaching, collaboration, model-based systems engineering, product design, report writing, requirements analysis, scripting languages, software architectures, software development management, software engineering practices, software quality assurance, systems development lifecycle, and technological savviness.

Responsibilities

Manage system requirements, ensuring they are structured, organized, maintained, and communicated across multidisciplinary and multisite teams.
Perform system-level risk analysis, including use risk analysis, in a highly regulated environment.
Collaborate with subsystem teams on requirements and risk cascade.
Work with cross-disciplinary teams to develop design strategies, system architectures, functional diagrams, and concepts.
Evaluate multifunctional solutions to identify and select designs that address specific requirements.
Partner with stakeholders to develop use cases and user stories that further define system user needs, design requirements, and system risks.
Provide systems engineering support for existing products and sustaining engineering activities.
Analyze mechanical, electrical, and software interfaces; support system integration and interface management to ensure system performance and reliability.
Partner with hardware, electrical, software, marketing, and testing teams throughout the product development lifecycle using a systems engineering approach.
Support regulatory submissions.
Ensure system requirements, designs, and deliverables meet Medical Device Electrical Safety (IEC 60601) requirements.
Coach team members on systems engineering methodologies and best practices.

Benefits

Retirement plan (pension) and savings plan (401(k)), subject to the terms of the plans.
Eligibility to participate in the long-term incentive program.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with different amounts stated for employees residing in Colorado (48 hours) and Washington (56 hours).
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 a child’s birth, adoption, or foster care placement.
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 rolling 52-week period.
Volunteer leave: 32 hours per calendar year.
Military spouse time-off: 80 hours per calendar year.