Design Assurance Manager

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.

Requirements:

  • 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.

+ Apply

Related Jobs

89 results found in the Engineering sector

Controls Engineer

  • Location: Galway
  • Job Type: Contract
  • Ref: 15336
  • Date Posted:

Our Galway based client are now recruiting for a Controls Engineer to join their team on a 12 month contract, for further information please contact Loretta on 086-1838380.Key ResponsibilitiesIncident Management:…

Manufacturing Engineer

  • Location: Galway
  • Job Type: Permanent
  • Ref: 15038
  • Date Posted:

Our Galway based client are now recruiting for a Manufacturing Engineer to join their team ...excellent opportunity not to be missed. For further information please contact Loretta on 086 1838380.Job…

Product Design Engineer

  • Location: Galway
  • Job Type: Contract
  • Ref: 15349
  • Date Posted:

Job Summary:The Product Design Engineer will be responsible for modeling/designing components for new and existing medical device products (e.g. assemblies/equipment/fixtures/programmers/leads/stents) into detail drawings and documentation using CAD and other tools.…

Supplier Quality Engineer

  • Location: Galway
  • Job Type: Permanent
  • Ref: 15363
  • Date Posted:

Cregg Recruitment are currently recruiting a Supplier Quality Engineer for a Galway based client, a leading medical device company. For more information please contact Ciara on 086 7868406.Responsibilities:Provides engineering support…

Validation Engineer

  • Location: Swords, Dublin
  • Job Type: Contract
  • Ref: CIM7120
  • Date Posted:

Role.Based on the client site in Swords, DublinPharmaceutical customer - so CSV experience essentialDealing with OEM package vendors - primarily delivered with Siemens TIA Portal technical solutions Reviewing and approving…

Can’t find the job for you?

Let us find the job made for you