Senior Design Assurance Engineer

Recruiter
HERO Recruitment
Employment Type
Permanent
Salary
Not disclosed
HERO Recruitment logo

Senior Design Assurance Engineer (Hybrid)
At our Client’s world leading Research & Development Department in Galway, they focus on the development of cutting-edge medical devices in the Cardiac and Vascular space. The successful candidate will be directly involved in the development of innovative products for use in medical procedures. This is a permanent position with hybrid working flexibility.

Key Responsibilities

  • You will serve as an extended team member on a new product development project representing the Design Assurance function and will report 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 a 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.

Key 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.
  • Understanding of mechanical-electrical medical systems, products, and therapies.

For further information on this role in please contact Mark Wilson on or email

Check out all our open jobs on our HERO Recruitment website –

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.