Dein persönlicher KI-Karriere-Agent
Senior Process Engineer(m/w/x)
Leading process development, validation, and technology transfer for medical devices. Hands-on process validation (IQ/OQ/PQ) and DRM knowledge required. Flexible work arrangement.
Anforderungen
- Strong knowledge of manufacturing process development, characterization, and scale-up in regulated environment
- Application drive and pragmatic engineering background
- Hands-on experience with process validation methodologies (IQ/OQ/PQ) and technology transfer
- Solid understanding of Design for Manufacturing and Reliability (DRM)
- Experience with risk management tools (e.g., FMEA)
- Experience with root cause analysis and structured problem-solving methods
- Proficiency in statistical analysis and data-driven decision making (DOE, SPC, capability analysis)
- Working knowledge of quality systems and regulatory requirements (e.g., FDA QSR, ISO 13485)
- Ability to interpret technical drawings, specifications and process requirements
- Strong cross-functional communication skills
- Strong technical leadership skills
- Strong know-how on materials engineering and materials science
- Capability to connect chemical, mechanical, and electrochemical phenomena to industry applications
Aufgaben
- Lead process development activities
- Lead technology transfer activities
- Lead validation activities
- Partner with R&D
- Partner with Quality
- Partner with Manufacturing
- Partner with Supply Chain
- Develop process experiments
- Execute process experiments
- Analyze experimental data
- Apply statistical methods
- Improve process capability
- Improve process yield
- Identify continuous improvement initiatives
- Implement cost reduction initiatives
- Implement risk mitigation initiatives
- Author technical documentation
- Review technical documentation
- Provide technical leadership
- Mentor junior engineers
- Mentor technicians
- Mentor operators
- Support process investigations
- Support root cause analysis
- Support resolution of process 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.
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 - SUSONITY
Process Validation Expert(m/w/x)
Vollzeitnur vor OrtSeniorAubonne - SMO Medtronic Europe Sàrl
Equipment Development Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanneab CHF 92.000 - 138.000 / Jahr
Senior Process Engineer(m/w/x)
Leading process development, validation, and technology transfer for medical devices. Hands-on process validation (IQ/OQ/PQ) and DRM knowledge required. Flexible work arrangement.
Anforderungen
- Strong knowledge of manufacturing process development, characterization, and scale-up in regulated environment
- Application drive and pragmatic engineering background
- Hands-on experience with process validation methodologies (IQ/OQ/PQ) and technology transfer
- Solid understanding of Design for Manufacturing and Reliability (DRM)
- Experience with risk management tools (e.g., FMEA)
- Experience with root cause analysis and structured problem-solving methods
- Proficiency in statistical analysis and data-driven decision making (DOE, SPC, capability analysis)
- Working knowledge of quality systems and regulatory requirements (e.g., FDA QSR, ISO 13485)
- Ability to interpret technical drawings, specifications and process requirements
- Strong cross-functional communication skills
- Strong technical leadership skills
- Strong know-how on materials engineering and materials science
- Capability to connect chemical, mechanical, and electrochemical phenomena to industry applications
Aufgaben
- Lead process development activities
- Lead technology transfer activities
- Lead validation activities
- Partner with R&D
- Partner with Quality
- Partner with Manufacturing
- Partner with Supply Chain
- Develop process experiments
- Execute process experiments
- Analyze experimental data
- Apply statistical methods
- Improve process capability
- Improve process yield
- Identify continuous improvement initiatives
- Implement cost reduction initiatives
- Implement risk mitigation initiatives
- Author technical documentation
- Review technical documentation
- Provide technical leadership
- Mentor junior engineers
- Mentor technicians
- Mentor operators
- Support process investigations
- Support root cause analysis
- Support resolution of process 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 through innovative 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 - SUSONITY
Process Validation Expert(m/w/x)
Vollzeitnur vor OrtSeniorAubonne - SMO Medtronic Europe Sàrl
Equipment Development Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanneab CHF 92.000 - 138.000 / Jahr