Unai Ibarretxe
Glostrup,84
Summary
Open minded person, solution oriented and target focused. Challenge driven; able to navigate in complexity and variety of situations. My career has been developed in the aircraft industry, both military and civil engines; and the medical devices industry, combination products and endoscopes; holding positions as development specialist, quality specialist and manager. Experienced on setting strategy and vision towards problem solving.
Overview
27
27
years of professional experience
Work History
Senior Manager Innovation
AMBU
04.2024 - Current
- Design Control. Medical Devices.
- Process innovation. Product development.
- Training. Design Control.
- Team management. Strategy and implementation.
Senior Specialist
Radiometer
01.2019 - Current
- Design and Risk Control
- Change Management and development
- Design optimization and Cost reduction
- Automation
- DFM
- Re-use
- Reliability and design flexibility
- Life cycle Management
Senior Associate
Biogen
01.2015 - 01.2019
- Standardization
- Process and product
- VSM and automation
- Risk and design Control
- Medical Devices
- NC.CAPA.Validation
- Standard Procedures
- GMP
Quality Specialist
Novo Nordisk
01.2008 - 01.2015
- Prototype manufacturing development
- DFM.Pilot line
- Full scale and ramp up production
- Implementation
- NC.CAPA.Validation
- Standard Procedures
- GMP
Quality Manager/Specialist
ITP.S.A.
01.2001 - 01.2008
- Personnel management and training
- Quality Factors monitoring
- Internal and external audits
- Product and prototype verification, process validation
- Design and Manufacturing Change approval
- First Article Inspection approval
Project Engineer
Saincal S.A.
01.2000 - 01.2001
Production Engineer
Otalora S.A.
01.1998 - 01.1999
Education
Certified release inspector - (RR)
01.2001
post grad - Wind and solar systems
01.2000
Master's Degree - Chemistry & Materials, Energy and Industrial processes, Mining
01.1997
Skills
- Risk and Design Control
- Product development and manufacturing
- Quality Management and Assurance
- Trackwise
- Master Control
- SAP
- Oracle
- Windchill
- Strategic Planning
- Cross-Functional Collaboration
- Operations Management
- Cross-functional Team Coordination
Coursescertificates
- GMP. (Annually trained)
- ISO13485 (Annually trained)
- ISO16949
- LEAN (Novo Nordisk A/S. Annually trained)
- Var tran (NNE )
- Validation (Novo Nordisk A/S)
- Risk and design Control. Annually trained.
References
By request
Hobbies and Interests
- Sports
- Health
- Motorcycles
- Science
Languages
Spanish
Native language
English
Proficient
C2
Danish
Advanced
C1
Timeline
Senior Manager Innovation
AMBU
04.2024 - Current
Senior Specialist
Radiometer
01.2019 - Current
Senior Associate
Biogen
01.2015 - 01.2019
Quality Specialist
Novo Nordisk
01.2008 - 01.2015
Quality Manager/Specialist
ITP.S.A.
01.2001 - 01.2008
Project Engineer
Saincal S.A.
01.2000 - 01.2001
Production Engineer
Otalora S.A.
01.1998 - 01.1999
post grad - Wind and solar systems
Master's Degree - Chemistry & Materials, Energy and Industrial processes, Mining
Certified release inspector - (RR)
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