Sr Robotics V&V Engineer

Johnson & Johnson Innovative Medicine; Boston (MA); On-site; USD 92,000 - 148,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Boston, MA is seeking a Senior Robotics Verification & Validation Engineer to join our Orthopaedics team. You will plan and execute V&V activities to meet FDA/ISO requirements for robotic medical devices, ensuring safety, effectiveness, and regulatory readiness.

You will collaborate with systems, software, hardware, and quality teams to define test strategies, develop protocols, and document results.

Qualifications

• Bachelor’s or Master’s in biomedical engineering, systems engineering or related field.
• 3+ years of V&V engineering in medical devices; Class II/III preferred.
• Experience with embedded systems, firmware testing, or electromechanical systems.

Responsibilities

• Collaborate with systems engineering to ensure requirements clarity and traceability.
• Define testable requirements post-change and risk-based approaches.
• Develop and execute V&V strategies, including verification protocols and regression plans.
• Prepare system-level V&V documentation and summarize results.
• Review subsystem verification deliverables for alignment with requirements.
• Design and implement manual and automated test setups for repeatability.
• Maintain robotics test lab facilities and ensure calibration and safety compliance.
• Ensure compliance with FDA, ISO 13485, IEC 60601, ISO 14971; support audits.

Skills

V&V Engineering

Test Automation

Embedded Systems

Python

LabVIEW

DOORS

Scripting

Technical Writing

Regulatory Knowledge

Education

Bachelor/Master in Biomedical Engineering

Systems Engineering

Electrical Engineering

Tools

DOORS

Jama

Polarion

LabVIEW

MATLAB

Python

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 the best talent to join our Orthopaedics team as a Senior Robotics Verification & Validation (V&V) Engineer to be located in Boston, MA.

Purpose:

The Senior Robotics Verification & Validation (V&V) Engineer is responsible for ensuring that robotic products meet all defined system and subsystem level requirements and are safe, effective, and compliant for their intended clinical use. This role plays a critical part in supporting regulatory submissions and product releases by planning, executing, and documenting comprehensive V&V activities in accordance with FDA regulations, ISO 13485, IEC standards, and other applicable regulatory and quality system requirements.

The Sr. Robotics V&V Engineer works cross functionally with systems, software, hardware, robotics, manufacturing, and quality teams to ensure design outputs are thoroughly verified and validated against user needs, intended use, system and subsystem requirements, and risk controls. This role requires strong technical depth, excellent collaboration skills, and the ability to operate effectively in a regulated, multidisciplinary environment.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Collaborate with systems engineering to ensure requirements clarity, testability, and traceability from user needs, system and sub-system requirements, through verification and validation.
• Define minimum testable requirements post-change (risk-based, essential performance, basic safety).
• Develop and execute comprehensive V&V strategies and master system test plansfor complex medical devices, including system verification protocols and regression plans that ensure robust requirements coverage; this includes investigational, integration, reliability, and formal V&V testing.
• Prepare and deliver system-level V&V documentation, including summary reports and verification results.
• Reviewing and approving sub-system verification deliverables to ensure alignment with overall system requirements.
• Design, validate, and implement test methods, including manual and automated test setups, to ensure they are suitable for verifying product requirements, including repeatability, reproducibility.
• Oversee the maintenance of robotics test lab facilities, ensuring all equipment and infrastructure are properly calibrated, serviced, and compliant with company safety, quality, and procedural standards; proactively identify and resolve issues to support uninterrupted testing and development workflows.
• Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 60601, ISO 14971).
• Support design transfer and product launch activities including complaints investigations.
• Investigate and document non-conformances, deviations, and test failures, drive root cause analysis and corrective actions.
• Interface with regulatory, quality, and manufacturing teams to support audits and inspections.
• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed
• Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams.
• Support project resource and schedule planning.

Qualifications / Requirements:

• Bachelor’s or master’s degree in biomedical engineering, Systems Engineering, Electrical Engineering, or related field.
• 3+ years of experience in V&V engineering within the medical device industry.
• Experience with Class II or Class III medical devices is preferred.
• Knowledge of embedded systems, firmware/software testing, or electromechanical systems is a plus.
• Strong understanding of systems engineering principles and product development lifecycle (e.g., V-model, waterfall, Agile).
• Experience with requirements management tools (e.g., DOORS, Jama, Polarion).
• Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB).
• Excellent technical writing and communication skills.
• Certification in CQE, CQA, or Six Sigma is a plus.
• Proficient in sample size calculation and statistical methods for analyzing data.

Location and Travel Requirements:

• In office expectations are a minimum of 3 days per week, up to 5 days per week depending on project demand.
• An estimate of travel up to 30% may be required both domestic and international

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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

#LI-PN2

Required Skills:

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 :

$92,000.00 - $148,350.00

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