Staff R&D Systems Engineer

Johnson & Johnson Innovative Medicine • Boston, MA

1d • $109,000 - $174,800 • Onsite

About The Position

This position will play an important role in the forefront of digital and robotic technology for the orthopedic medical device industry. As a Staff Systems Engineer, you will be responsible for system requirements generation and performing risk analysis for orthopedic robotic platforms among other system engineering tasks including sub-system integration. Additionally, you will work with cross-disciplinary teams to update and maintain system architectures, user interfaces and instructions for use as well as support subsystem coordination. Communication and collaboration with cross-disciplinary teams will be essential for success.

Requirements

• BS 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 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/Graduate degree in engineering preferred.

Responsibilities

• Perform requirements management, ensuring requirements are structured, organized, maintained, and communicated across multi-disciplined and multi-site teams.
• Responsible for performing system level risk analysis, including use risk analysis, in a highly regulated environment.
• Collaborate with sub system teams on requirements and risk cascade.
• Collaborate with cross-disciplinary teams developing design strategies, system architectures, functional diagrams and participate in the generation of concepts.
• Evaluate multi-functional solutions to help identify and select the best design answers for specific requirements.
• Partner with key partners to develop use cases and user stories to further define system user needs, design requirements and system risks.
• Provide continuing systems engineering support to existing products and sustaining engineering activities.
• Analyze mechanical, electrical, and software interfaces. Work with cross functional teams on system integration and interface management, ensuring high system performance and reliability.
• Partner with hardware engineering, electrical engineering, software engineering, marketing, and testing using a systems engineering approach throughout the product development lifecycle.
• Support regulatory submissions.
• Ensure system requirements, designs and deliverables meet Medical Device Electrical Safety (IEC 60601) Requirements.
• Coach team members on System Engineering methodologies and best practices.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior