QvalFocus Inc. · 12 hours ago
SW Design Quality Engineer (Medical Device & Firmware)
Minnesota, United States
Contract
Onsite
Mid LevelQvalFocus Inc. is seeking a SW Design Quality Engineer to support the development of a next-generation medical device console. The engineer will collaborate with firmware and software teams to ensure design quality, compliance, and risk management throughout the development process.
Staffing & Recruiting
No H1B
Hiring Manager
Prabhakar Vempati
Responsibilities
Support early-stage development by planning and executing design quality activities
Manage software design changes through the CCB process while ensuring compliance with FDA and IEC standards (21 CFR Part 11, IEC 62304)
Participate in Agile/SCRUM activities, including sprint planning and daily stand-ups
Support risk management, including software and cybersecurity risks
Review test protocols, test reports, and validation documents
Perform software code reviews and design reviews to ensure quality and compliance
Assist in cybersecurity risk assessments for the product
Qualification
Required
Strong background in Medical Device Software Quality
Hands-on knowledge of IEC 62304, ISO 14971, and ISO 13485
Understanding of design inputs and software development lifecycle
Experience with capital equipment and/or SaMD
Working experience with JAMA and JIRA
Experience in Agile/SCRUM environments
Technically strong with basic cybersecurity understanding
Experience supporting firmware and system-level software development
Company
QvalFocus Inc.
QvalFocus: Focused on Delivering Quality that sets us Apart.
Founded in 2024
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase