Design Assurance Engineer required for a global Medical Device company in Galway. This is a permanent role and offers excellent career progression.
A DAY IN THE LIFE OF:
· 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 SKILLS & EXPERIENCE
· 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.