Computer System Validation Jobs in Boston, MA (NOW HIRING)

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Job Function:

R&D Product Development

Job Sub Function:

Robotics

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, 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 hiring for Navigation Systems Verification & Validation (V&V) Engineering Manager in a hybrid role to be based out of Raynham or Boston, MA

Purpose:

The Navigation Systems Verification & Validation (V&V) Engineering Manager is responsible for ensuring that navigation products meet all defined system and subsystemlevel 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 Navigation Systems V&V Engineering Manager leads a team of Verification & Validation and Integration Engineers, providing technical and people leadership to ensure that navigation systems meet all subsystem and systemlevel requirements throughout development and release.

Working crossfunctionally with systems, software, hardware, clinical, navigation, manufacturing, and quality teams, the Navigation Systems V&V Engineering Manager ensures that 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 and leadership skills, and the ability to operate effectively in a regulated, multidisciplinary environment.

Job Responsibilities:

Lead a team of Verification & Validation and Integration Engineers to ensure navigation systems meet all defined subsystem and systemlevel 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 riskbased 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 investigational, 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 restrictedmaterials laboratories) to ensure full regulatory compliance and adherence to internal company policies.

Oversee the maintenance of navigation systems 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:

Required:

Bachelor's or master's 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).

Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB).

Excellent technical writing and communication skills.

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.

Experience in surgical robotics or surgical navigation technologies is a major plus.

. 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 www.careers.jnj.com

#LI-PN2

Required Skills:

Preferred Skills:

Computer Programming, Consulting, Critical Thinking, Data-Driven Decision Making, Data Science, Developing Others, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Manufacturing Technologies, Product Knowledge, Prototyping, Quality Assurance (QA), Research and Development, Robotic Automation, SAP Product Lifecycle Management, Team Management

The anticipated base pay range for this position is :

$117,000.00 - $201,250.00

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