Staff R&D Systems Engineer

Johnson & Johnson Co.; Boston (MA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation 120 hours/year

Sick time 40 hours/year (varies by US)

Holiday pay

Job summary

Johnson & Johnson is seeking a Staff R&D System Engineer based in Boston to lead system requirements, risk analysis, and cross-disciplinary design activities for orthopedic robotic platforms. You will coordinate with hardware, software, and marketing teams through the product development lifecycle to ensure compliant, safe, and effective medical devices.

The role emphasizes collaboration, system architectures, interfaces, and supporting regulatory submissions in a highly regulated

Qualifications

• 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 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.

Responsibilities

• Perform system requirements management across multi-disciplined and multi-site teams.
• Conduct system-level risk analysis in a regulated environment.
• Collaborate with subsystem teams on requirements and risk cascade.
• Develop design strategies, architectures, and functional diagrams with cross-disciplinary teams.
• Evaluate multi-functional solutions to identify best design answers for requirements.
• Develop use cases and user stories to define system needs and risks.
• Provide ongoing systems engineering support to existing products and sustaining activities.
• Analyze interfaces and ensure high system performance and reliability.

Skills

Orthopedic dev

Robotics experience

Design Controls

V&V testing

Regulatory knowledge

Education

BS in Systems, Biomedical Eng, Robotics or Mechatronics

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 www.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 Staff R&D System Engineer to be based out of Boston, Massachusetts, USA. We have pre identified candidate for this role, but encourage others to apply as well.

Purpose:

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.

Job 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.

Qualifications / Requirements:

• BS in Systems, Biomedical Engineering, Robotics, or Mechatronics.
• Advanced/Graduate degree in engineering preferred.
• 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.

Preferred Skills:

• Computer Programming, Cost-Benefit Analysis (CBA), Critical Thinking, Data Science, Industry Analysis, Innovation, Manufacturing Technologies, Organizing, Problem Solving, Process Improvements, Prototyping, Quality Assurance (QA), Quality Control (QC), Research and Development, Robotic Automation, SAP Product Lifecycle Management, Technical Credibility
• Agility Jumps, Analytical Reasoning, Coaching, Collaboration, Critical Thinking, Model-Based Systems Engineering (MBSE), Product Design, Report Writing, Requirements Analysis, Research and Development, SAP Product Lifecycle Management, Scripting Languages, Software Architectures, Software Development Management, Software Engineering Practices, Software Quality Assurance (SQA), Systems Development Lifecycle (SDLC), Technologically Savvy

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.

Equal Opportunity Statement:

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.

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

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.

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