Senior HW Sustaining Engineer

Details

  • Category: Medical devices
  • Location: Lausanne area
  • Starting date: Nov 01, 2019
  • Domain of experience: HW, hardware, electronics, sustaining engineering, obsolescence
  • Level required: Experienced
  • Years of experience: 8+

Your Role

Senior HW Sustaining Engineer will join the global and well-known medical devices company in Lausanne.

In this role, you will be mainly responsible for the engineering activities regarding the obsolescence issues of the injectors' components (electro-mechanical and software-controlled medical devices).

Your Tasks

  • Identify released product design and manufacturing process issues, evaluate critical nature, determine root cause, develop design and process solutions, and implement them
  • Manage projects for product enhancements and obsolescence projects that enable improve cost, quality and the continued supply of product for worldwide operations
  • Design and develop creative engineering solutions
  • Manage technical relationship with suppliers and subcontractors
  • Adapt process steps including associated documentation part of the DMR operations
  • Develop and maintain documentation like design specifications, verification test plans, project schedules, drawings, and change orders associated with medical devices and consumable products
  • Provide hands-on support for products from commercial release to the end of life
  • Support Junior team members with expert knowledge
  • Ensure product meets requirements (FDA, UL, CE and others)
  • Participate in the selection of vendors and fabrication sources to assure quality and compliance to released specifications

Your Profile

  • University Degree in Electromechanical Engineering / Manufacturing or System Engineering (or equivalent)
  • Minimum 8 years of experience in the Medical Devices industry
  • Specialist product sustaining engineering experience (hardware)
  • Background in complex projects/programs management
  • Knowledge Quality System and Medical Standards, ISO, EN, IQOQ, DFM, FMEA, ECF
  • Experience in implementing design changes with Contract Manufacturers and in managing suppliers
  • Injection moulding tooling and processing knowledge is a plus
  • Great communication skills
  • Fluency in English

 

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