Medical Device Design Quality Engineer

Location: Austin, Texas, USA; onsite role. Travel requirements are up to 10%.

Company

hirify.global develops clinically differentiated medical technologies and integrated solutions for orthopedics and active lifestyles.

What you will do

• Support new product development and sustaining product development as the quality assurance representative.
• Participate in design and manufacturing reviews, risk analysis discussions, and health hazard evaluations.
• Generate DFMEAs and UFMEAs and review and approve design and development documentation.
• Author quality system procedures and work instructions and conduct internal audits.
• Evaluate nonconforming materials, review device failure trends, and lead corrective and preventive actions.
• Act as a design quality subject matter expert during ISO and FDA audits and ensure compliance with GMP, ISO, FDA, and MDD requirements.

Requirements

• Bachelor’s degree in Biomedical or Mechanical Engineering and 3+ years of experience, including at least 1 year in a design-focused environment, or an equivalent combination of education and experience.
• Experience in medical devices, aeronautics, automotive, or another highly regulated industry.
• Knowledge of quality technical writing, manufacturing processes, metrology, precision machining, grinding, product cleaning, and sterilization.
• Knowledge of Microsoft Office or equivalent software.
• Ability to sit or stand for long periods and lift, carry, or pull up to 25 lbs.

Nice to have

• Knowledge of ISO 13485 quality standards, ISO 14971, and risk management principles.
• Experience with SolidWorks, SolidWorks ePDM, Oracle R12, or Agile PLM.
• CQE, Lean, or Six Sigma certification.
• Detail-oriented and analytical approach.

Culture & Benefits

• Collaborative work with partners and patients in a scientific, continuous-improvement environment.
• Opportunity to contribute to medical technology and patient outcome improvements.
• Equal employment opportunity based on merit, experience, and work-related criteria.
• Reasonable accommodation is available for qualifying beliefs and practices.