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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 Management

Job Sub** **Function:

QA/Test Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Madison, Wisconsin, United States of America

Job 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, and presentation communications

o Technical writing: requirements, protocols, testing results, procedures, status, and special reports

o Knowledge and understanding of medical regulations and their impact on business, ISO (International Organization for Standardization) and GMP (Good Manufacturing Practices)

o Quality, statistical process controls

o Effective team interpersonal skills

o Able to: work efficiently and effectively in an ambiguous environment, adapt to shifting priorities, handle rapid pace environment, resolve problems/conflicts, take initiative and be self-managing

o General design engineering principles

o Design of experiments (DOE)

o DFMEA (design failure mode effect analysis) principles, PFMEA (process failure mode effect analysis) principles

o Working knowledge of either electrical, mechanical, or software testing of systems, sub-systems, and components

o Knowledgeable of medical terminology, procedures, and instrumentation

TECHNICAL (MECHANICAL or ELECTRICAL or SOFTWARE):

Mechanical

o Knowledgeable of basic mechanical engineering principles.

Electrical

o Knowledgeable of basic electrical engineering principles.

o Working knowledge of generators and/or powered ultrasonic, RF, and electro-mechanical medical devices

Software

o Software verification and validation methods

o Experience testing of embedded, real-time software, microcontroller-based firmware, low-level device drivers, or software related to user interface and middle layer business logic.

Required Skills:

Preferred Skills:

Analytical Reasoning, Data Savvy, Detail-Oriented, Execution Focus, Human-Computer Interaction (HCI), Incident Management, Process Oriented, Project Management, Quality Assurance (QA), Quality Control (QC), Quality Processes, Quality Services, Quality Systems Documentation, Robotic Automation, Software Development Management, Software Reliability Engineering, Technologically Savvy, Test Planning