Tina Halmen
Hechingen
Summary
Accomplished medical engineering professional with over 16 years of specialized experience in medical device development, risk management, and quality assurance. Demonstrates a comprehensive understanding of ISO 14971, Medical Device Regulation, and global regulatory standards. Expertise includes leading risk analysis teams, crafting compliant technical documentation, supporting regulatory submissions, and managing CAPA processes effectively. Recognized for strong cross-functional communication skills and extensive knowledge in post-market surveillance, product risk files, FMEAs, and regulatory interactions. Prepared to leverage senior-level expertise to enhance the effectiveness of a global quality engineering team.
Overview
16
16
years of professional experience
2
2
Certification
Work History
Risk Manager
Maquet Cardiopulmonary GmbH (Getinge Group)
08.2009 - Current
- Lead development and maintenance of ISO 14971-compliant risk management documentation.
- Moderate international cross-functional risk analysis teams.
- Evaluate post-market surveillance data and residual risk.
- Deliver internal training on risk management processes.
- Respond to inquiries from Notified Bodies and regulatory authorities.
- Support risk assessments for field actions and benefit–risk analyses.
Development Engineer
Maquet Cardiopulmonary GmbH (Getinge Group)
02.2009 - 07.2019
- Coordinated CAPA activities including root cause analysis and corrective actions.
- Created technical documentation in accordance with 93/42/EEC.
- Performed product risk assessments for process deviations.
- Supported risk management activities across R&D, Quality, and Manufacturing.
- Provided manufacturing support in Turkey to ensure quality alignment.
Education
Dipl.-Ing. (FH) - Medical Engineering
University Of Applied Science
Furtwangen / Villingen - Schwenningen07-2008
German Abitur (Equivalent To High School Diploma) -
Lessing Gymnasium
Hoyerswerda, Germany09-2002
Skills
- Data-Driven Decision Making
- Cross-functional collaboration
- Risk mitigation strategies
- Teamwork
- Problem-solving
Certification
- Risk Management for Medical Devices including materials with biological origin - Certified (08/2025)
- Aspects of Software Risk Management - Basic Course (09/2024)
- Lean Administration - Basic Course (10/2023)
- IEC 60601-1 - Basic Course (06/2023)
- FMEA Moderator - Certified (09/2021)
- Regulatory Requirements of Sterile Products - Basic Course (01/2020)
- Medical Product Consultant acc. to §31 MPG - Certified (10/2019)
- Risk Management DIN EN ISO 14971 (03/2019)
Languages
English
Advanced (C1)
German
Bilingual or Proficient (C2)
Spanish
Beginner (A1)
Timeline
Risk Manager
Maquet Cardiopulmonary GmbH (Getinge Group)
08.2009 - Current
Development Engineer
Maquet Cardiopulmonary GmbH (Getinge Group)
02.2009 - 07.2019
Dipl.-Ing. (FH) - Medical Engineering
University Of Applied Science
German Abitur (Equivalent To High School Diploma) -
Lessing Gymnasium
Interests:
Tennis ( member of a local tennis club)