Design Assurance Engineer (Medical Devices)

TL;DR

Design Assurance Engineer (Medical Devices): Ensuring quality and regulatory compliance for medical devices and consumables with an accent on design control, risk management, and FMEA processes. Focus on reviewing verification and validation specifications, conducting failure analysis, and maintaining adherence to international standards like ISO 14971 and MDR.

Location: Berlin, Germany (Onsite)

Company

hirify.global is a global leader in precision technology, providing mission-critical components and sub-systems for healthcare and advanced manufacturing industries.

What you will do

• Create and manage overall quality plans and design control documentation.
• Review design verification and validation specifications for medical equipment and consumables.
• Lead and contribute to product and design FMEA teams.
• Manage risk assessment processes throughout the product development lifecycle according to ISO 14971.
• Collaborate with Quality Assurance and Production to define test requirements for series testing.
• Perform failure analysis for field returns and development-stage issues.

Requirements

• Completed technical or physical studies.
• At least 2 years of professional experience in a highly regulated industry (medical devices, automotive, or aviation).
• Fluency in English is required.
• Strong knowledge of quality methods, techniques, and regulatory standards (MDR, CFR820, GLP, GDP).
• Structured, systematic approach to work with a focus on quality and reliability.
• Willingness to travel (10%) to business locations.

Nice to have

• Proficiency in German.

Culture & Benefits

• Global team environment with over 26 offices worldwide.
• Culture focused on teamwork, collaboration, and empowerment.
• Opportunity to work on innovative, mission-critical medical technology.
• Equal employment opportunity workplace.