Our client, a medical device company in Galway is currently looking to recruit a Design Assurance Manager for their site.
We have an exciting opportunity for a Sustaining Engineering Design Assurance Manager to support Peripheral Interventions (PI) divisions in Galway:
- Creating and maintaining a culture of commitment to improving patient safety, customer satisfaction and product quality in BSC.
- Assuring compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry.
- Promoting and effecting compliance to BSC’s quality, business and health & safety systems and market/legal regulations.
- Analysing, reducing and managing risks associated with the design, use and manufacture of BSC devices.
- Providing expertise in BSC’s product development systems to project teams
- Supervising, leading and coaching members of the design assurance department
- Driving functional excellence in Design Assurance SE 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 PI 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 SE team metrics, CAPA, shelf life, PMS and other initiatives to drive agile and efficient work.
- Interface with R&D and DA SE managers to provide prioritization of work for the DA team.
- Lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and drive best practices throughout their organization.
- Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Direct and control the activities and budget of one or more functional areas and/or projects/programs.
- Determines appropriate staff levels and schedules.
- Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
Qualifications and Experience:
- 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.
- Knowledge/Experience of Design Controls and FDA/ISO Medical Device Regulations.
- B.S. Technical Degree such as Mechanical Engineering, Materials Science and/or Biomedical Engineering.
- Advanced degree in a technical field or business
- Understanding of risk management and design controls tools and requirements for medical device product development.
For further information on this Design Assurance Manager role in Galway please contact Alan Prendergast on 0860462367/ email@example.com
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