System Engineer (Medical Devices)

Location: Prelouc, Czech Republic

Company

hirify.global develops engineered components and subsystems for healthcare and advanced manufacturing applications, including minimally invasive surgery, robotics, and 3D metal printing.

What you will do

• Evaluate and document product changes based on system architecture, specifications, risk management, regulations, and standards.
• Develop verification, validation, and test plans for product changes.
• Plan and execute product tests, validations, and data analysis.
• Monitor the technical progress of product change projects and support project management and manufacturing engineering.
• Create and maintain technical documentation, standard operating procedures, and validation reports.
• Collaborate with quality teams and lead adoption of hirify.global Growth System principles.

Requirements

• Bachelor’s degree in Engineering, preferably Mechanical or Manufacturing Engineering.
• At least 1 year of manufacturing support experience in medical manufacturing and/or quality.
• Knowledge of medical device production and regulatory standards, including ISO 13485 and ISO 14791.
• English at B2 level is required for daily spoken and written communication.
• Understanding of statistical and analytical tools, plus problem-solving methods such as FMEA, 8D, or Six Sigma.
• Experience with MS Office; SAP or a similar ERP system is a plus.

Nice to have

• Knowledge of medical materials and their requirements.
• Knowledge of SAP or a similar ERP system.

Culture & Benefits

• Full-time position with opportunities to work in a global organization.
• Collaboration across engineering, manufacturing, quality, and project management functions.
• Occasional travel to other hirify.global facilities, approximately 10–20%.
• No specific physical requirements are listed.