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Risk Manager Medical Devices(m/w/x)
Risk management for innovative drug delivery products, coordinating FMEA teams at a medical device manufacturer. Engineering degree and regulated medical device experience essential. Active product shaping role, flexible working time.
Anforderungen
- Master or Bachelor in Engineering
- Experience in ISO14971 or FMEA documentation
- Experience in regulated medical device industries
- AAMI TIR38-2019 documentation experience (plus)
- Desire for creative team collaboration
- Independent and structured working style
- Attention to detail and documentation skills
- Excellent communication skills
- Good English and German skills
Aufgaben
- Maintain and develop risk management files per ISO 14971
- Perform continuous risk assessments throughout the product life cycle
- Coordinate the design FMEA team and document results
- Lead the production process FMEA team and record findings
- Develop Safety Case documentation following US Standard AAMI TIR38-2019
Berufserfahrung
- 3 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- ISO14971
- FMEA
- AAMI TIR38-2019
Benefits
Flexibles Arbeiten
- Flexible working time
Sinnstiftende Arbeit
- Active product shaping role
Lockere Unternehmenskultur
- Friendly and international team
Sicherer Arbeitsplatz
- Prospective permanent position
Weiterbildungsangebote
- Job related training events
Noch nicht perfekt?
- B. Braun Miethke GmbH & Co. KGVollzeitmit HomeofficeBerufserfahrenPotsdam
- B. Braun Miethke GmbH & Co. KG
Embedded Systems Test Engineer(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenPotsdam - B. Braun Miethke GmbH & Co. KG
Senior Development Engineer(m/w/x)
Vollzeitmit HomeofficeSeniorPotsdam - B. Braun Miethke GmbH & Co. KG
Senior Entwicklungsingenieur(m/w/x)
Vollzeitmit HomeofficeSeniorPotsdam - Alcon
Image Processing Engineer - Medical Devices(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenTeltow
Risk Manager Medical Devices(m/w/x)
Risk management for innovative drug delivery products, coordinating FMEA teams at a medical device manufacturer. Engineering degree and regulated medical device experience essential. Active product shaping role, flexible working time.
Anforderungen
- Master or Bachelor in Engineering
- Experience in ISO14971 or FMEA documentation
- Experience in regulated medical device industries
- AAMI TIR38-2019 documentation experience (plus)
- Desire for creative team collaboration
- Independent and structured working style
- Attention to detail and documentation skills
- Excellent communication skills
- Good English and German skills
Aufgaben
- Maintain and develop risk management files per ISO 14971
- Perform continuous risk assessments throughout the product life cycle
- Coordinate the design FMEA team and document results
- Lead the production process FMEA team and record findings
- Develop Safety Case documentation following US Standard AAMI TIR38-2019
Berufserfahrung
- 3 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- ISO14971
- FMEA
- AAMI TIR38-2019
Benefits
Flexibles Arbeiten
- Flexible working time
Sinnstiftende Arbeit
- Active product shaping role
Lockere Unternehmenskultur
- Friendly and international team
Sicherer Arbeitsplatz
- Prospective permanent position
Weiterbildungsangebote
- Job related training events
Über das Unternehmen
B. Braun Miethke GmbH & Co. KG
Branche
Healthcare
Beschreibung
B. Braun Miethke develops innovative drug delivery products to meet unmet user and patient needs.
Noch nicht perfekt?
- B. Braun Miethke GmbH & Co. KG
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Vollzeitmit HomeofficeBerufserfahrenPotsdam - B. Braun Miethke GmbH & Co. KG
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Vollzeitmit HomeofficeBerufserfahrenPotsdam - B. Braun Miethke GmbH & Co. KG
Senior Development Engineer(m/w/x)
Vollzeitmit HomeofficeSeniorPotsdam - B. Braun Miethke GmbH & Co. KG
Senior Entwicklungsingenieur(m/w/x)
Vollzeitmit HomeofficeSeniorPotsdam - Alcon
Image Processing Engineer - Medical Devices(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenTeltow