Sr Test Validation Engineer I

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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

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 https://www.jnj.com/. 

This is a field-based role available in all cities within Massachusetts. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Sr Test Validation Engineer I.

Purpose: Seasoned individual contributor, who works independently with minimal supervision. Implements processes and activities related to fulfilling the Quality Assurance requirements for the organization's products.

You will be responsible for:

• Understand device design and core technologies in order to support platform teams to develop validation strategy.
• Design comprehensive test plan, and create detailed test protocols that ensure they align with design and regulatory requirements.
• Design and Validate test method and associated test fixture/system.
• Conduct risk assessments to identify potential failure modes and their impact on patient safety and device performance.
• Lead investigations into test failures, performing root cause analysis to resolve underlying issues.
• Collaborate with design, development, and quality teams to resolve issues and implement corrective actions.
• Prepare and maintain detailed documentation of test procedures, test fixture work instructions, and SOPs to meet regulatory and quality management system (QMS) requirements.
• Identify opportunities to improve testing processes, methodologies, and tools to enhance efficiency and effectiveness.
• Provide guidance and mentorship to team members, helping to develop their skills and knowledge.
• Work closely with cross-functional teams, including R&D, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration of testing activities.
• Manage testing tools, equipment, and software, ensuring they are calibrated and validated for use.
• Communicate test results, risks, and issues to collaborators, including management, customers, and regulatory bodies, in a clear and concise manner.

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.

#LIOnsite

Required Skills:

 

 

Preferred Skills:

Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

 

 

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

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.



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