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Manager Verification and Validation Lab (f/m) in Heerbrugg, Switzerland at Leica Microsystems

Date Posted: 2/17/2019

Job Snapshot

Job Description

Job ID: RES000079

About Us

Leica Microsystems is a world leader in microscopes and scientific instruments. Founded as a family business in the nineteenth century, the company’s history was marked by unparalleled innovation on its way to becoming a global enterprise. 

Its historically close cooperation with the scientific community is the key to Leica Microsystems’ tradition of innovation, which draws on users’ ideas and creates solutions tailored to their requirements. At the global level, Leica Microsystems is organized in three divisions, all of which are among the leaders in their respective fields: the Life Science Division, Industry Division, and Medical Division.

Leica Microsystems has five manufacturing facilities in four countries, with sales and service organizations in 20 countries. The company is headquartered in Wetzlar, Germany



Description

  • Definition of the strategy and planning of all V&V activities
  • Responsible for the definition and improvement of test processes, techniques, tools and laboratory management
  • Improvement and extension of automated duration testing
  • Definition, improvement and implementation of SOPs
  • Verification and validation planning, execution and reporting according the applicable standards, directives and regulations for medical devices
  • Participation in review meetings of requirements, specification, design and finally verification and validation reports
  • Coach, motivate and engage with direct reports to drive Verification and Validation to the next level by having a motivated and high performing, winning team
  • Planning of the team resources across all projects according schedules and all other lab topics.
  • Responsible for the test area, equipment park and test infrastructure
  • Responsible for the on-time delivery of the R&D part for the Device History File (main lead is with RA/QA) plus user documentation (IFU)
  • Support with production issues and customer complaints plus proposals for product improvement and cost savings
  • Support of the production during design transfer in NPI projects including the Outgoing Inspection planning and reporting

Job Requirements



Qualifications

  • Bachelor or Master in Mechanical or Medical Engineering
  • Minimum 7 years of experience in the area of Verification, Requirement Management and Traceability, out of that in minimum 5 years in the field of Medical Devices.
  • Minimum 5 years of technical experience in team management and / or management of complex projects
  • Experience in Risk management for Medical Devices
  • Familiar with regulated (medical) environment (FDA/GMP, QSR, IVDD, ISO 13485), and Laboratory- and Test automation
  • Experience in Quality Engineering is appreciated
  • Further education in QSR requirements and Project Management is appreciated
  • Strong written and verbal German and English communication skills
  • Ability to create a V&V Strategy for Medical by understanding risks, strengths, weaknesses, opportunities and threats and translates this into actionable plans
  • Proven leadership skills with the ability to take the lead in a team, manage by influence and also function as a team player



Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

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