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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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- IQ/OQ/PQ
- FMEA
- DOE
- SPC
- FDA QSR
- ISO 13485
Benefits
Flexible Working
- Flexible work arrangement
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- IQ/OQ/PQ
- FMEA
- DOE
- SPC
- FDA QSR
- ISO 13485
Benefits
Flexible Working
- Flexible work arrangement
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
SMO Medtronic Europe Sàrl
Industry
Healthcare
Description
The company leads global healthcare technology and addresses challenging health problems through innovative solutions.
Not a perfect match?
- SMO Medtronic Europe Sàrl
Senior Process Engineer(m/w/x)
Full-timeOn-siteSeniorLausannefrom CHF 111,200 - 166,800 / year - SMO Medtronic Europe Sàrl
Quality Engineer(m/w/x)
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Process Validation Expert(m/w/x)
Full-timeOn-siteSeniorAubonne - SMO Medtronic Europe Sàrl
Equipment Development Engineer(m/w/x)
Full-timeOn-siteExperiencedLausannefrom CHF 92,000 - 138,000 / year