Sr. Verification Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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Quantum Surgical Incorporatedhas entered into an agreement with Johnson & Johnsonto 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 Incorporatedand your employment would be governed by Quantum Surgical Incorporated employment processes programs policies and benefit that case details of any planned changes would be provided to you by Quantum Surgical Incorporated at an appropriate time and subjectto 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 FMEAs 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.

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