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Senior Design Assurance Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 19124

Our client a Major Multinational here in Galway are looking to hire a Senior Design Assurance Engineer.


The Role:

The Senior Design Assurance Engineer will provide quality engineering leadership on key programs in new product development in Peripheral Vascular Health. 

Responsibilities


  • You will serve as an extended team member on a new product development project representing the Design Assurance function and will report the dotted line to the Quality lead on the project.
  • Apply knowledge of design control principles and quality engineering techniques throughout the product development process
  • Identify and manage risk using an FMEA and/or other risk management tools.
  • Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
  • Establish verification and validation strategies with R&D and Regulatory to ensure an efficient approval path.
  • Develop master test plans that encompass design verification, design validation and process validation activities that are sufficient to meet regulatory requirements and quality objectives.
  • Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
  • Apply understanding of anatomy & physiology with engineering knowledge in materials and processes to come up with designs.
  • Interface effectively and build relationships with team members, other staff, and key technology and component suppliers, both locally and globally.

Requirements:

  • Qualified person to Bachelor/Master’s Degree level 8 in Mechanical, Biomedical or related engineering discipline and with a minimum of 2 years relevant experience.
  • Dynamic team player and can work effectively and proactively on cross-functional teams.
  • Collaborate across organizational boundaries and take appropriate actions when problems occur.
  • Be an experienced professional in engineering development with extensive engineering knowledge and skills in some or all of the following: risk management, component and system design, sterilization of medical devices, test method development, component qualification, pre-clinical evaluations, physician interactions, knowledge of anatomical use conditions (anatomy, physiology etc.), system requirements development, design control, application of ISO standards for medical devices.
  • Skills in Microsoft Excel, Word, PowerPoint and Minitab etc.
  • A good communicator and fluent in English, both in writing and speaking
  • High level of enthusiasm and motivation, and the ability to take input from others are desirable.
  • Understanding of mechanical-electrical medical systems, products, and therapies.

For more information or a confidential discussion about this role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706 717