A Major Medical Devices Company in Galway, Ireland wish to recruit a suitably qualified person for the following post:
SENIOR DESIGN ASSURANCE ENGINEER
In the world-leading Research & Development Department, there is a focus on the development of cutting-edge medical devices in the Cardiac and Vascular space. Engineers are directly involved in the development of innovative products for use in medical procedures. The Senior Design Assurance Engineer provides quality engineering leadership on key programs in new product development for endo-venous products.
* Apply knowledge of design control principles and quality engineering techniques throughout the product development process.
* Identify and manage risk using a FMECA 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 assure 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.
* Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
* 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.
* You are 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, materials (polymers and metals), sterilization of medical devices, test method development, design for six sigma principles, 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.
* You are 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.
REMUNERATION: An excellent Salary/Benefits Package is on offer and negotiable
Please forward your CV in WORD FORMAT to:
Informal enquiries to Christy O'Hara on 087-9473404 or 00353 879473404 (if outside Ireland)