Senior Design Assurance Engineering Manager
Our client, a medical device company in Galway are currently looking to recruit a Sr Compliance/Audit Specialist for their site.
Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let's work together to address the universal healthcare needs and improve patients' lives, optimize costs and efficiencies, and expand global access. Together, we can make a real difference in the global disparity in care. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together.
In our Coronary and Renal Denervation Design Assurance Team, our purpose is to increase product development process rigour to ensure robust understanding of designs, documentation of compliance to requirements and timely, high-quality product launches that satisfy patient needs and reduce customer complaint rates. The Senior Design Assurance Engineering Manager is directly involved in providing high level leadership and direction to the DAE team, ensuring the implementation of strategic and tactical activities supporting the Coronary and Renal Denervation Business Unit.
You will champion the application of Design, Reliability, Manufacturing (DRM) practices, methods, and tools. You will ensure all product evaluations from prototype testing to design verification are managed to the highest quality standards in compliance with corporate, regulatory and GMP requirements. You will develop strong cross functional teamwork with all functions involved in product development and maintain strong links with similar functions across CRDN and the wider business to develop and harmonise systems and practices. You will apply clinical knowledge of product use to ensure appropriate quality and design decisions are made and to support the development of bench simulations/tests to evaluate new product design. You will contribute to establishing department goals; budgets, measurement and metrics systems in line with business objectives to ensure quality standards are achieved and thus ensure that new product development projects are effectively managed. You will be responsible for continuous improvement activities as determined in goals and objectives, and for forecasting and managing department headcount allocation. You will participate in building a strong design assurance engineering team by hiring qualified candidates, coaching & mentoring your team members and supporting them in their ongoing professional development. You will support your engineering team by providing ongoing supervision, and establishing and actively managing performance expectations. You will maintain up-to-date knowledge of quality system regulations and industry practices applicable to areas of responsibility.
- We are looking for a qualified person to Level 8 Degree in Engineering / Science or related technical discipline and desirably with 10+ years relevant experience.
- You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams. You are experienced in supporting the practical applications of quality principles in at least one of the Quality Strategy Pillars; Design, Manufacturing, Supplier or Vigilance & Compliance.
- Experienced manager with proven leadership skills and experience in oversight of process improvement tools (e.g. DRM, six sigma). Strong decision making, judgment and influencing skills are desirable.
- You are a good communicator and fluent in English, both in writing and speaking.
Leadership Expectations provide the framework for what we expect from all employees - outlining the actions and behaviours we must develop and demonstrate in pursuit of our Mission and global growth goals.
For further information on this Senior Design Assurance Engineering Manager role in Galway please contact Bimi Felix on 0868395533 / firstname.lastname@example.org
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