Supervisor Design Assurance Engineers (m/f/d)

TL;DR

Supervisor Design Assurance Engineers (m/f/d) (Medical Devices): Lead the local Design Assurance team in Berlin and actively contribute as a Design Assurance Engineer to ensure product quality and regulatory compliance across medical device development with an accent on Design Control, verification/validation planning, and ISO 14971 risk management. Focus on building quality plans, reviewing V&V and Design Control documentation, and supporting FMEA, NC/CAPA, and process improvements.

Location: Berlin, Germany

Company

hirify.global develops engineered components and sub-systems for healthcare and advanced manufacturing.

What you will do

• Provide first-level leadership to the local Design Assurance team in Berlin and coordinate daily priorities and execution.
• Create overall quality plans, including document plans and V&V strategies, and develop design verification and validation plans for medical devices.
• Review Design Control documentation for compliance with GLP, GDP, and FDA 21 CFR 820.
• Act as a member of the risk management team and ensure completeness/consistency of risk analyses and evidence for risk control effectiveness (ISO 14971).
• Contribute to Product/Design FMEA, support series test specifications, manage calibration of measuring equipment, and perform failure analysis of non-conforming units.
• Support NC/CAPA activities in accordance with ISO 13485 and drive process improvements and harmonization.

Requirements

• Degree in Engineering, Physics, or a related technical field.
• 5 years of professional experience in a regulated industry.
• Experience in product quality within highly regulated industries (medical devices preferred; automotive or aviation accepted).
• Knowledge of ISO 13485 and quality management systems.
• Experience with quality and statistical methods, plus system/reliability/software/hardware testing experience.
• English: minimum B2 level and willingness to travel (approx. 10%).

Culture & Benefits

• Work in a global team with offices across the Americas, Europe, and Asia-Pacific.
• First-line leadership role with responsibility for team engagement and development.
• Focus on quality, compliance, and continuous process improvement.
• Travel expected for the role (approx. 10%).