Senior Robotics Verification & Validation (V&V) Engineering Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

People Leader

All Job Posting Locations:

Boston Massachusetts United States of America Raynham Massachusetts United States of America

Job Description:

About Orthopaedics
Fueled by innovation at the intersection of biology and technology were 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 thats 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 are hiring for Senior Robotics Verification & Validation (V&V) Engineering Manager in a hybrid role to be based out of Raynham or Boston MA

Purpose:
The Senior Robotics Verification & Validation (V&V) Engineering Manager 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 Senior Robotics V&V Engineering Manager leads a team of Verification & Validation and Integration Engineers providing technical and people leadership to ensure that robotic systems meet all subsystem and system level requirements throughout development and release.
Working cross functionally with systems software hardware clinical robotics manufacturing and quality teams the Senior Robotics V&V Engineering Manager ensures that design outputs are verified and validated against user needs intended use system and subsystem requirements and risk controls. This role requires strong technical depth excellent collaboration and leadership skills and the ability to operate effectively in a regulated multidisciplinary environment.

Key Responsibilities:
In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:
Lead a team of Verification & Validation and Integration Engineers to ensure robotic systems meet all defined subsystem and system level requirements.
Collaborate closely with systems engineering hardware and software teams to ensure requirements are clearly defined testable and fully traceable from user needs and system/subsystem requirements through verification and validation.
Define minimum testable requirements following design or requirement changes applying a risk based approach that considers essential performance and basic safety.
Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices including system verification protocols and regression strategies to ensure robust requirements coverage. This includes oversight of investigation integration reliability and formal verification and validation 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.
Coordinate and manage engagement with external test facilities (e.g. NRTLs EMC and restricted materials laboratories) to ensure full regulatory compliance and adherence to internal company policies.
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.
Communicate business-related issues or opportunities to next management level
Follow 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
Ensure personnel and Company compliance with all Federal State local and Company regulations policies and procedures
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:
Required
Bachelors or masters degree in biomedical engineering Systems Engineering Electrical Engineering or related field.
7 years of experience in V&V engineering within the medical device industry.
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).

Preferred
Experience with Class II or Class III medical devices is preferred.
Knowledge of embedded systems firmware/software testing or electromechanical systems is a plus.
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.

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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Johnson & Johnson is an Affirmative Action and 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 or protected veteran status and will not be discriminated against based on disability.
For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit
#LI-PN2

Required Skills:

Preferred Skills:

Developing Others Inclusive Leadership Innovation Leadership Operations Management Process Improvements Requirements Analysis Research and Development Researching SAP Product Lifecycle Management Scripting Languages Software Acquisitions Software Development Management Software Engineering Practices Software Quality Assurance (SQA) Stakeholder Engagement Systems Development Lifecycle (SDLC) Tactical Planning Team Management Technologically Savvy Vendor Management

The anticipated base pay range for this position is :

$137000.00 - $235750.00

Additional Description for Pay Transparency:

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



This position is eligible to participate in the Companys 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: - Experience:

Manager