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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
Noch nicht perfekt?
- SMO Medtronic Europe SàrlVollzeitnur vor OrtSeniorLausanneab CHF 111.200 - 166.800 / Jahr
- SMO Medtronic Europe Sàrl
Quality Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenTolochenazab CHF 92.000 - 138.000 / Jahr - SMO Medtronic Europe Sàrl
Intern Process Development Engineering(m/w/x)
VollzeitPraktikumnur vor OrtLausanneab CHF 2.000 - 2.500 / Monat - SMO Medtronic Europe Sàrl
Intern Process Development Engineering(m/w/x)
VollzeitPraktikumnur vor OrtLausanneab CHF 2.000 - 2.500 / Monat - SMO Medtronic Europe Sàrl
Associate Calibration Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanneab CHF 123.480 / Jahr
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
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 - SMO Medtronic Europe Sàrl
Quality Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenTolochenazab CHF 92.000 - 138.000 / Jahr - SMO Medtronic Europe Sàrl
Intern Process Development Engineering(m/w/x)
VollzeitPraktikumnur vor OrtLausanneab CHF 2.000 - 2.500 / Monat - SMO Medtronic Europe Sàrl
Intern Process Development Engineering(m/w/x)
VollzeitPraktikumnur vor OrtLausanneab CHF 2.000 - 2.500 / Monat - SMO Medtronic Europe Sàrl
Associate Calibration Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanneab CHF 123.480 / Jahr