Within the Coronary Design Assurance Group we focus on providing Quality support across all aspects of PDP from pre market product development to post market product surveillance. We participate in the design process to ensure the performance and safety of the coronary devices we develop, is assured and maintained throughout the product lifecycle.
Support the product development team and be responsible for supporting activities required to ensure development and validation of robust Test Methods. You will work closely with your Design Assurance team, product development engineering, clinical, marketing and regulatory to assure appropriate Test Methods are developed & Validated for the specific device application and target patient population.
- Responsibilities may include the following and other duties may be assigned.
- Undertakes and successfully completes complex test method development tasks including: creation, writing, test method validation, equipment qualification and supporting on-going maintenance of test methods.
- Leads or participates in a cross functional team to translate product specifications into test methods.
- You will liaise with extended team members to facilitate timely completion of Test Method Validation activities.
- Devise strategies for efficient execution of project deliverables and co-ordinate activities of a number of staff in an assigned phase of a development project.
- You will provide technical expertise in test method development and validation supporting new development projects.
- You will liaise with other functions to ensure robust test method development meeting all stakeholders' requirements.
- You will generate new test methods and test method related equipment and fixtures with all supporting materials.
- Lead and solve complex problems to resolution and solution implementation.
- As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer and commercialization activities.
- Translates international standards and regulatory guidance into test methods.
- Works independently to plan and schedule own activities necessary to meet timelines.
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
- We are looking for a qualified person to Minimum of a Bachelor's degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Mechatronics, Science) and desirably with a minimum of 5 years relevant experience.
- Experience with Solidworks or CAD Software, fixturing or model fabrication, anatomical knowledge, statistical knowledge.
- You are a dynamic team player, can work effectively and proactively on cross-functional teams.
- Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.
- You are a good communicator and fluent in English, both in writing and speaking.