Design Quality Engineer (Medtech)

TL;DR

Design Quality Engineer (Medtech): Implementing and leading design quality activities for medical device product development and sustaining projects with an accent on regulatory compliance and risk management. Focus on ensuring product designs meet FDA, ISO 13485, and global standards through rigorous verification, validation, and design control processes.

Location: Must be based in Carlsbad, California, USA

Company

hirify.global is an innovation-driven medical technology company dedicated to developing clinically differentiated solutions that improve patient outcomes and transform healthcare workflows.

What you will do

• Lead design quality engineering activities for New Product Introduction (NPI) and sustaining projects.
• Review and approve design specifications, test plans, engineering drawings, and verification/validation protocols.
• Manage the risk management process, including hazard analyses and failure modes and effects analyses (FMEA).
• Ensure compliance with FDA QSR, ISO 13485, and other global regulatory standards.
• Conduct internal audits, manage CAPA investigations, and support FDA/Notified Body inspections.
• Coordinate design transfer activities, including process validation and first article inspections.

Requirements

• Bachelor's degree in Science or Engineering.
• Minimum 3+ years of experience in a quality engineering role.
• Required certification: CQA, RABQSA, CQE, or CMfgE.
• Strong knowledge of FDA/GMP, CMDR, MDD, and ISO 13485 standards.
• Ability to interpret mechanical drawings, GD&T, and assembly diagrams.
• Experience with manufacturing processes, inspection tools, and clean room technology.

Culture & Benefits

• Opportunity to work on innovative medical technology solutions.
• Commitment to continuous improvement and global talent development.
• Equal employment opportunity employer valuing diverse contributions.