Design Assurance Engineering Program Manager
Our client, a medical device company in Galway are currently looking to recruit a Design Assurance Engineering Program Manager for their site.
- In our Heart Valve Therapy 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 Design Assurance Engineering Program Manager will be assigned as the lead Quality extended team member for the delivery system reporting directly to the functional Senior DA manager and dotted line to the Quality core team leader for the project.
- As Quality extended Core Team Member, you will develop strong cross functional partnerships with all functions involved in the program.
- The program aims to develop a disruptive and innovative therapy for Trans Aortic Valve Therapy.
- You will lead the quality function in the development of the delivery system and are accountable to the quality core team member for the program.
- Excellent communication skills are required as you will be responsible for communicating key program information including exceptions, barriers, and quality issues to the Core Team, extended team, and functional management to ensure full engagement and alignment.
- In particular you will support the application of Design, Reliability, Manufacturing (DRM) practices, methods, and tools with the other technical core team members.
- You will be responsible for a number of elements on the NPD Program and Developing Quality functional strategies and schedules to meet project goals.
- Proactively identifying and managing quality related project risks, and partnering with Quality functional management to identify, plan and allocate the required resources.
- As part of ongoing professional development you will also be supported in maintaining up-to-date knowledge of quality system regulations, industry practices applicable to areas of responsibility, and developments in clinical practice.
- We are looking for a qualified person to Level 8 Degree in Engineering / Science or related technical discipline and desirably with 10+ year's 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.
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