Design Assurance Engineer

TL;DR

Design Assurance Engineer (Medical Devices): Creation of an overall quality plan and review of design verification/validation specifications, test specifications, and Design Control documents for medical devices with an accent on GDP/CFR820 compliance and ISO 14971 risk management. Focus on building and reviewing FMEA outputs, evaluating risk-reducing measures, and supporting evidence for implementation and effectiveness during product development.

Location: Brno

Company

hirify.global develops engineered components and sub-systems for healthcare and advanced manufacturing, including minimally invasive surgery devices.

What you will do

• Support creation of the overall quality plan, including document plan and overall V&V plan, within design control.
• Review design verification and validation test specifications, test requirements, and related test reports for medical devices (equipment and consumables).
• Review Design Control documents according to GDP and CFR820/GLP requirements.
• Contribute as a member of the product and design FMEA team and support risk management activities.
• Participate in ISO 14971 risk management: contribute to risk content, review completeness of risk analysis, evaluate risk-reducing measures, and create/review evidence of implementation and effectiveness.
• Perform failure analysis for field returns and during development, and coordinate with Quality Assurance and Production on series testing preparation.

Requirements

• Completed engineering studies.
• At least 2 years of professional experience.
• Experience with product quality in a highly regulated industry (medical device preferred).
• Experience applying quality methods and techniques.
• English: B2 required.
• Willingness to travel to Berlin (10%).

Culture & Benefits

• Extra week of vacation (25 days/year) plus 5 sick days per calendar year.
• Flexible working hours (core 10:00–15:00) and flexible time off for charitable activities.
• Meal vouchers and meal allowance for working from home (max 2 days/week).
• Training and language courses with career advancement support.
• Company pension contribution after probation and annual wage reassessment from 1 April.
• Modern workplace perks: MultiSport, free refreshments, free parking, shower facilities, and dog-friendly/family-friendly environment.