Senior HW System Engineer m/f

Lausanne Permanent

added 24/11/2021

  • International company - In-Vitro Diagnostic - Medical device (Class III)
  • Instrument development - Assay integration - Project Management - ISO13485

About Our Client

Our client is an international medical device company, specialized in the design and manufacturing of an In-vitro diagnostic system.

Job Description

* Understand the needs of product assay workflow and develop associated Instrument design inputs.
* Work directly with a third-party partner to develop instrument solutions to meet the design input needs.
* Provide technical project management to ensure development solutions meet the internal stakeholder needs.
* Drive the third-party partner to deliver to project timelines and meet/or exceed key milestones.
* Ensure all development activities are in compliance with regulatory requirements, ensuring adherence to life cycle requirements.
* Lead cross-functional project teams as required to deliver product improvements.
* Experience in development of complex, sophisticated, software controlled electromechanical medical devices / IVD Instruments.
* Participate in Design Reviews to ensure key milestone deliverables are achieved.
* Lead and support risk management activities, including FMEA's, to ensure robust and reliable designs
* Lead, develop and implement design characterization, DOE's and design verification strategies for efficient, complete and robust testing through report completion and anomaly resolution or independently perform tolerance, error budget or other design analysis by extending or adapting existing methodologies.
* Detailed understanding of medical device regulations including ISO, FDA GMP and design controls.Key Objectives
* Strong experience in documenting medical device requirements (design inputs) with accuracy and testing outputs to ensure inputs are achieved.
* Expert understanding of medical device / IVD instrument life cycle.
* Clear understanding and experience of risk management; using risk management tools and techniques to develop solutions.
* Solid understanding of manufacturing systems
* Working application of Lean/Six Sigma methodologies is required.
* Must be able to demonstrate a strong collaborative working style
* Experience of leading a team
* Strong report writing and presentation skills are essential.
* Flexibility to travel, primarily in Europe. Travel needs will vary but circa 20% of time.

The Successful Applicant

  • Primary Degree in Bio Mechanical Engineering / Electrical or Electro Mechanical Engineering.
  • Experience in IVD product development (preferred), medical device experience may suit if supported by relevant IVD business understanding.
  • Strong working knowledge of Electromechanical Design, Requirements Definition and V&V activities.
  • Manufacturing experience in a Medical device/manufacturing environment with specific emphasis on improvement methodologies
  • Experience in optical system design/evolution and characterisation,
  • Must be very capable of communicating in a clear and concise manner.
  • Excellent presentation and report writing skills.
  • Ability to present to all levels within the organisation,
  • Excellent attention to detail,
  • French and English fluent, German is a strong asset,

What's on Offer

CV in PDF format

Ghislain de Miribel
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Job summary

Contract Type
Consultant name
Ghislain de Miribel
Job Reference

PageGroup is an equal opportunity employer committed to workforce diversity, both as an employer as well as a recruitment service provider. Each recruitment decision we make for people we hire and people we place into new roles is based solely on the candidates’ knowledge, experience and skills.