Our Galway based client are now recruiting for a Design Assurance Manager to join their team, for further information please contact Loretta on 086 1838380.
Key Responsibilities :
- Driving functional excellence in Design Assurance by providing coaching and mentoring on product design change and material change best practices and ensuring technical excellence.
- Hiring, guiding, training and developing world-class staff to provide technical leadership for multiple sustaining projects.
- Provide leadership to implementation of EUMDR across the Division in partnership with Regulatory and Clinical.
- Working cross-functionally in identifying and resolving technical issues, takes a pro-active role in building bridges across the organization to mitigate issues.
- Driving and evaluating project and department progress, technical development plans, and results.
- Provide leadership and guidance to support the Quality initiatives including product performance based complaint reduction.
- Lead the DA team metrics, CAPA, shelf life, PMS and other initiatives to drive agile and efficient work.
- Interface with R&D and DA managers to provide prioritization of work for the DA team.
- Bachelor's degree plus 8-10 years of related work experience or an equivalent combination of education and work experience.
- Proven technical leadership and project management skills in medical device design, development and commercial launch.
- Proven key leadership traits of: ability to be independent critical thinker, strong communication skills and ability to build effective cross-functional relationships
- Ability to interface with customers to gather insight and get organizational buy-in on key design inputs.
- Understanding of risk management and design controls tools and requirements for medical device product development.
- Knowledge/Experience of Design Controls and FDA/ISO Medical Device Regulations.