Sr Test Validation Engineer I

Johnson & Johnson•Danvers, MA

20h•$94,000 - $151,800•Onsite

About The Position

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/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.

Nice To Haves

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)

Responsibilities

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.

Benefits

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