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SMSMO Medtronic Europe Sàrl

Senior Process Engineer(m/w/x)

Lausanne
from CHF 111,200 - 166,800 / year
Full-timeOn-siteSenior

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

  • EnglishBusiness Fluent

Tools & Technologies

  • IQ/OQ/PQ
  • FMEA
  • DOE
  • SPC
  • FDA QSR
  • ISO 13485

Benefits

Flexible Working

  • Flexible work arrangement
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SMO Medtronic Europe Sàrl and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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