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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
Apply now

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.

Requirements

  • 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

Tasks

  • 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

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
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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