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Process Development Engineer

At our Process Development Department we focus on designing and developing cutting edge technologies for the manufacture of medical devices in the Cardiac & Vascular Group. Our Engineers are directly involved in the development of innovative products and processes for use in medical procedures.

Job Description

As an engineer you will actively participate in all areas of product transfers including the following: Design, Technology development & advancement, Automation, Vendor management, Cell operating System (COS) & Project management.

Responsibilities

  • You will support all activities related to equipment development and validation to meet internal and regulatory (CE) requirements.
  • You will support process development, characterization and validation activities.
  • You will use Design, Reliability & Manufacturability methodology (DRM), 3-D drawing/printing and Augmented reality to develop best in class technologies for the manufacture of our medical device product ranges.
  • You will collaborate with cross functional teams to define, execute and deliver on program deliverables.
  • You will utilize your new and existing skillsets in six sigma tools, project management and technology development to solve technical problems.
  • You will compile, document and present all learnings to project and functional teams.

Requirements

  • Third Level 8 Degree or higher in Electronic, Electrical, Mechanical or Biomedical Engineering or related discipline and desirably with experience in a similar role.
  • Dynamic team player and can work effectively and proactively on cross-functional teams * Knowledge of medical device processes with a good understanding of product and process design.
  • Good communicator and fluent in English, with a high level of enthusiasm and motivation.
  • Good organizational, presentation and project management skills are desirable * Develops technical / Equipment documentation including Equipment binders , Equipment validations and technical reports in accordance with quality system requirements.
  • Support the development and sourcing of vendors, Co-ordinate and liaise with vendors to ensure equipment is sourced to budget and on time.
  • Supports verification, validation, and implementation of equipment for both design and process development
  • Utilizes knowledge of FDA and ISO / CE / EH&S requirements related to equipment / process development, ensuring robust validation and qualification