Sr. Verification Engineer
Johnson & JohnsonAbout the role
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:
Technology Product & Platform ManagementJob Sub Function:
QA/Test EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Madison, Wisconsin, United States of AmericaJob Description:
Quantum Surgical Incorporated has entered into an agreement with Johnson & Johnson to acquire the NEUWAVE business. The process is anticipated to be completed in Q1 2026, subject to legal requirements, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following the conclusion of the transaction, you would be transferred from Johnson & Johnson to Quantum Surgical Incorporated. At that time, you would become an employee of Quantum Surgical Incorporated, and your employment would be governed by Quantum Surgical Incorporated employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by Quantum Surgical Incorporated at an appropriate time and subject to any necessary legal processes.
This role supports testing and product needs for new products and products that are currently released. Provides engineering and design services to manufacturing and production engineering groups. Develops concepts, designs and details for machines, tools, fixtures, and products. Responsibility also includes ensuring that cost, performance, and customer satisfaction goals are met. Provides guidance, mentoring, and direction to less experienced engineers. Establishes and coordinates all testing resources for the NeuWave R&D team. May serve in a project lead engineer role.
DUTIES & RESPONSIBILITIES:
o Provide innovative platform, product, system, sub-system, and component testing solutions
o Establish appropriate statistical testing strategies to ensure adequate safety factors or margins
o Perform appropriate statistical product testing to ensure adequate safety factors or margins
o Formalize testing of concepts and prototypes
o Contribute to and/or coordinate testing of the integration of complex system and sub-system product medical device designs
o Provide peer feedback and may mentor junior associates as required
o Participate in the development and update of Design FMEA’s to analyze the impact of design-related risks.
o May provide direction to consultants & contractors who may be working with the team on a development project
o Be the point of contact with external testing facilities, including communication of all testing requirements
o Create or update Verification and Validation Protocols
o Contribute to Design Reviews
o Create Tools and Test Equipment Specifications
o Conduct complaint investigations
o Create document change orders
o Complete CAPAs as assigned
o Responsible for the execution of system verification protocols
o Lead testing activities for engineering projects. Projects may be new development or sustaining engineering projects
o Responsible for a roadmap of NeuWave testing activities
EXPERIENCE AND EDUCATION:
o B.S. degree in Biomedical, Electrical, Mechanical, or Software Engineering (Required)
o Generally, requires 6 or more years of product testing experience in a product development environment (preferably in the medical products or device industry working in a team-based environment)
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS:
o Basic understanding and working knowledge of current US & foreign government regulations regarding the design and manufacture of medical devices
o Effective oral, written, an
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