Our client a major multinational based here in Galway are looking for a Reliability Engineer II.
- 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.
- Apply knowledge of design control principles and quality engineering techniques throughout the product development process.
- You will contribute to the product development team and be responsible for supporting activities required to ensure the development and validation of new product introduction.
- 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.
- Responsible for generation of design verification protocols & will participate in the compilation of design verification and shelf-life data for regulatory submissions to support design change approval.
- 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.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
- Minimum of a bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Science), with 2+ years of experience in Engineering, and Quality.
- A dynamic team player, who can work effectively and proactively on cross-functional teams with good communication and technical writing skills.
For more information on this role and a confidential discussion please contact Michelle Mc Inerney on
091 706 717 or email firstname.lastname@example.org