Design Quality Engineer (Medical Devices)

Location: Austin, Texas, USA; onsite office setting

Company

hirify.global develops clinically differentiated medical technology, products, services, and integrated technologies for orthopedics and active lifestyles.

What you will do

• Support new product development, sustaining product development, and special instrument teams as the quality assurance representative.
• Participate in design and manufacturing reviews, risk analysis discussions, and the preparation of DFMEAs and UFMEAs.
• Review and approve design and development documentation.
• Author procedures and work instructions governing the quality system.
• Conduct internal quality system and business-function audits and serve as a design quality subject matter expert during ISO and FDA audits.
• Evaluate nonconforming materials, analyze device-failure trends, and lead corrective and preventive actions.

Requirements

• Bachelor’s degree in Biomedical or Mechanical Engineering and 3+ years of experience.
• Experience in medical devices, aeronautics, automotive, or another highly regulated industry.
• Knowledge of manufacturing processes including metrology, precision machining, grinding, cleaning, and sterilization.
• Knowledge of quality system regulations and standards, including GMP, ISO, FDA, and MDD; ISO 13485 knowledge is preferred.
• Technical writing skills and proficiency with Microsoft Office, especially Excel and Word.
• Fluent English, written and verbal, is required; travel may be up to 10%.

Nice to have

• Experience with SolidWorks, SolidWorks ePDM, Oracle R12, or Agile PLM.
• CQE, Lean, or Six Sigma certification.
• Advanced knowledge of ISO 14971 and risk management principles.
• Spanish, German, or French language skills.

Culture & Benefits

• Work in a general office environment with low to moderate noise levels.
• Collaborate across engineering, manufacturing, quality, and regulatory functions.
• Contribute to a culture focused on continuous improvement, common goals, and measurable outcomes.