Advanced Design Quality Engineer

April 6, 2025
Reference key: ES14074
Permanent
Deadline date:

Job Description

Advanced Design Quality Engineer required by innovative MedTech company for hybrid role in Munich. My client is a high-growth start-up dedicated to developing cutting-edge technologies that solve critical global clinical needs. Join a passionate, creative and diverse team applying world-class engineering and design expertise to bring breakthrough hardware, software and data science solutions to life.

They are now seeking to recruit an Advanced Design Quality Engineer to join the team in Munich. Reporting to the Quality Manager, you’ll be instrumental in ensuring that ground-breaking medical devices meet the highest regulatory and quality standards.

RESPONSIBILITIES:

  • Drive quality engineering activities aligned with ISO 13485 and FDA QSR (21 CFR Part 820)

  • Lead risk management processes (ISO 14971) including FMEA and hazard analysis

  • Ensure compliance across software lifecycle (ISO 62304) and usability engineering (ISO 62366)

  • Oversee standards related to electrical and mechanical safety (ISO 60601-1, 60601-2-37)

  • Support the creation and review of medical device labeling

  • Execute design V&V and test method validation plans

  • Represent Quality in design reviews, change control boards and regulatory audits

  • Contribute to CAPA, non-conformances, document control and internal audits

  • Collaborate on cybersecurity and AI validation for medical devices

REQUIREMENTS:

  • You are a detail-oriented problem-solver with a passion for quality and innovation in medical device design

  • Bachelor’s degree in Engineering, Quality, or related field

  • 4+ years of experience in medical device design quality

  • Strong knowledge of relevant standards: ISO 13485, 14971, 62304, 62366, 60601 series

  • Experience with FDA QSR, risk management tools (FMEA, FTA) and V&V processes

  • Familiarity with PLM systems, document control and internal auditing

  • A collaborative mindset and excellent communication skills

  • Project management skills and a proactive attitude

  • Willingness to travel up to 25% 

Benefits:

  • Work on innovative medical systems that directly impact patient care

  • Be part of a high-performing, international team that values growth, diversity and collaboration

  • Enjoy a flexible hybrid work environment

  • Access to continuous learning and personal development opportunities