R&D Systems Engineer

Biopharma Asia; Boston (MA); On-site; USD 78,000 - 127,000; Full time

Job summary

Johnson & Johnson in Boston seeks a System Engineer to join the Orthopaedics digital and robotic technology team. You will participate in system requirements generation, risk analysis, and cross-disciplinary collaboration to define architectures and support integration.

The role involves development, verification, validation, regulatory support, and creating technical materials for stakeholders. Ideal candidates have 1-2 years in medical device development, a BS in an engineering field, and

Qualifications

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

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.

Skills

Analytical reasoning

MBSE

Requirements analysis

Scripting languages

Problem solving

Technical writing

Regulatory knowledge

Education

BS in Systems

Biomedical Engineering

Robotics

Mechatronics

Advanced degree

Tools

SAP PLM

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Product Development

Job Sub Function:

R&D Software/Systems Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Boston, Massachusetts, United States of America

Job Description:

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for 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 in 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.

Johnson & Johnson announced plans to separate our 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Required 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

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

The anticipated base pay range for this position is :

$78,000.00 - $126,500.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits