System Engineer (Medtech)

TL;DR

System Engineer (Medtech): Supporting product validation and manufacturing engineering processes for medical device components with an accent on regulatory compliance and risk management. Focus on developing test plans, executing validations, and maintaining technical documentation within a high-precision manufacturing environment.

Location: Must be based in Prelouc, Czech Republic (Hybrid role with home office flexibility).

Company

hirify.global is a global leader in precision engineered components and sub-systems for mission-critical applications in healthcare and advanced manufacturing.

What you will do

• Evaluate and document product changes based on system architecture and risk management standards.
• Develop and execute test and verification plans for product validations.
• Monitor technical progress of product change projects.
• Collaborate with the quality department to ensure adherence to ISO 13485 and ISO 14791 standards.
• Prepare and review technical documentation and standard operating procedures.
• Manage the organization and maintenance of test rooms and laboratories.

Requirements

• Bachelor’s degree in Engineering (Mechanical or Manufacturing preferred).
• 1+ years of experience in medical manufacturing or quality support.
• English B2 level required for daily communication.
• Understanding of medical device production and regulatory standards (ISO 13485, ISO 14791).
• Proficiency in problem-solving tools such as FMEA, 8D, or Six Sigma.
• Experience with statistical analysis tools and MS Office.

Nice to have

• Knowledge of SAP or similar ERP systems.
• Understanding of medical materials usage and requirements.

Culture & Benefits

• International work environment with professional growth opportunities.
• Stability within the medical devices industry.
• Flexible working hours and home office options.
• 25 days of vacation.
• Additional perks including free lunches, Edenred card, and travel allowance.