Staff R&D Systems Engineer

6149-DePuy Synthes Products Inc. Legal Entity; Boston (MA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Retirement plan (401k)

Long-term incentive program

Paid time off

Job summary

Johnson & Johnson is seeking a Staff R&D System Engineer in Boston, MA to shape requirements and risk analyses for orthopedic robotic platforms. You will work with hardware, software and clinical teams to drive architectures and interfaces across the development lifecycle.

The role emphasizes collaboration, design controls, and regulatory readiness, enabling safe, innovative digital and robotic solutions in orthopedics.

Qualifications

• In-depth systems engineering knowledge for orthopedic robotic platforms.
• Experience with medical device product development and risk management.
• Familiarity with IEC 60601, ISO 14971, ISO 13485, 62366 and regulatory submissions.

Responsibilities

• Perform system requirements generation and risk analysis for orthopedic robotic platforms.
• Collaborate across hardware, software and marketing teams throughout product lifecycle.
• Support regulatory submissions and ensure IEC 60601 compliance.
• Develop system architectures, interfaces, and validation strategies with cross‑disciplinary teams.
• Coach team members on System Engineering methodologies and best practices.

Skills

Systems Engineering

Risk Analysis

Cross-functional teamwork

Regulatory Knowledge

Surgical Robotics

MBSE

Design Controls

Test & Verification

Education

BS in Systems engineering / Biomedical engineering / Robotics / Mechatronics

Advanced/Graduate degree in engineering

Tools

MBSE

Design Controls

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 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.

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

Staff R&D System Engineer – Boston, Massachusetts, USA

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

Pay Transparency

The anticipated base pay range for this position is: $109,000.00 - $174,800.00

Benefits and Time Off

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

Employer 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.