Dein persönlicher KI-Karriere-Agent
Senior Process Engineer(m/w/x)
Leading process development and validation for medical devices in a regulated environment. Pragmatic engineering background with process validation methodologies required. Flexible work arrangement, 6 weeks vacation.
Anforderungen
- Strong knowledge of manufacturing process development, characterization, and scale-up in regulated environment
- Pragmatic engineering background
- Hands-on experience with process validation methodologies (IQ/OQ/PQ)
- Hands-on experience with technology transfer
- Solid understanding of Design for Manufacturing and Reliability (DRM)
- Solid understanding of risk management tools (e.g., FMEA)
- Experience with root cause analysis
- Experience with structured problem-solving methods
- Proficiency in statistical analysis
- Proficiency in data-driven decision making (DOE, SPC, capability analysis)
- Working knowledge of quality systems
- Working knowledge of regulatory requirements (e.g., FDA QSR, ISO 13485)
- Ability to interpret technical drawings
- Ability to interpret specifications
- Ability to interpret process requirements
- Strong cross-functional communication skills
- Strong technical leadership skills
- Strong know-how on materials engineering
- Strong know-how on materials science
- Capability to connect chemical phenomena to industry applications
- Capability to connect mechanical phenomena to industry applications
- Capability to connect electrochemical phenomena to industry applications
Aufgaben
- Lead process development, technology transfer, and validation
- Partner cross-functionally with R&D, Quality, Manufacturing, and Supply Chain
- Develop and execute process experiments (DOE)
- Analyze data and apply statistical methods
- Identify and implement continuous improvement initiatives
- Identify and implement cost reduction initiatives
- Identify and implement risk mitigation initiatives
- Author technical documentation
- Review technical documentation
- Provide technical leadership to junior engineers
- Provide mentorship to junior engineers
- Support investigations of process-related issues
- Support root cause analysis of process-related issues
- Support resolution of process-related issues
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- IQ/OQ/PQ
- FMEA
- DOE
- SPC
- FDA QSR
- ISO 13485
Benefits
Flexibles Arbeiten
- Flexible work arrangement
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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- SMO Medtronic Europe SàrlVollzeitnur vor OrtSeniorLausanneab CHF 111.200 - 166.800 / Jahr
- SUSONITY
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Senior Process Engineer(m/w/x)
Leading process development and validation for medical devices in a regulated environment. Pragmatic engineering background with process validation methodologies required. Flexible work arrangement, 6 weeks vacation.
Anforderungen
- Strong knowledge of manufacturing process development, characterization, and scale-up in regulated environment
- Pragmatic engineering background
- Hands-on experience with process validation methodologies (IQ/OQ/PQ)
- Hands-on experience with technology transfer
- Solid understanding of Design for Manufacturing and Reliability (DRM)
- Solid understanding of risk management tools (e.g., FMEA)
- Experience with root cause analysis
- Experience with structured problem-solving methods
- Proficiency in statistical analysis
- Proficiency in data-driven decision making (DOE, SPC, capability analysis)
- Working knowledge of quality systems
- Working knowledge of regulatory requirements (e.g., FDA QSR, ISO 13485)
- Ability to interpret technical drawings
- Ability to interpret specifications
- Ability to interpret process requirements
- Strong cross-functional communication skills
- Strong technical leadership skills
- Strong know-how on materials engineering
- Strong know-how on materials science
- Capability to connect chemical phenomena to industry applications
- Capability to connect mechanical phenomena to industry applications
- Capability to connect electrochemical phenomena to industry applications
Aufgaben
- Lead process development, technology transfer, and validation
- Partner cross-functionally with R&D, Quality, Manufacturing, and Supply Chain
- Develop and execute process experiments (DOE)
- Analyze data and apply statistical methods
- Identify and implement continuous improvement initiatives
- Identify and implement cost reduction initiatives
- Identify and implement risk mitigation initiatives
- Author technical documentation
- Review technical documentation
- Provide technical leadership to junior engineers
- Provide mentorship to junior engineers
- Support investigations of process-related issues
- Support root cause analysis of process-related issues
- Support resolution of process-related issues
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- IQ/OQ/PQ
- FMEA
- DOE
- SPC
- FDA QSR
- ISO 13485
Benefits
Flexibles Arbeiten
- Flexible work arrangement
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
SMO Medtronic Europe Sàrl
Branche
Healthcare
Beschreibung
The company leads global healthcare technology and addresses challenging health problems by finding solutions.
Noch nicht perfekt?
- SMO Medtronic Europe Sàrl
Senior Process Engineer(m/w/x)
Vollzeitnur vor OrtSeniorLausanneab CHF 111.200 - 166.800 / Jahr - SUSONITY
Process Validation Expert(m/w/x)
Vollzeitnur vor OrtSeniorAubonne - SMO Medtronic Europe Sàrl
Quality Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenTolochenazab CHF 92.000 - 138.000 / Jahr - SMO Medtronic Europe Sàrl
Equipment Development Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanneab CHF 92.000 - 138.000 / Jahr