Senior Design Assurance Engineer

Pale Blue Dot Recruitment

  • Galway
  • Permanent
  • Full-time
  • 1 month ago
  • Apply easily
The Role

Reporting to the Design Assurance Manager, you will be Working predominantly on projects to introduce or improve products for treatment of a range of peripheral arterial disease states. The Design Assurance Engineer will support the Company’s product development and commercialisation strategy.

Responsibilities
  • Work within the quality system and ensuring that the quality policy and company systems and procedures are complied with
  • Provide Design Assurance input to R&D project teams for designated projects
  • Understanding the Regulatory requirements for device developments and providing input to projects to encompass these requirements.
  • Lead in specification development in relation to design input development.
  • Participate in the generation of Design Input / Output documents.
  • Lead the risk management activities for designated projects and design changes.
  • Design, development and validation of test methods as required to support development programs.
  • Develop and maintain design verification and validation plans, protocols and reports.
  • Support R&D in the preparation and delivery of Design Reviews and associated checklists.
  • Support the execution of non-clinical studies at third party facilities, in conjunction with R&D department.
  • Establish and maintain the Design History File and associated documents.
  • Provide QA support to R&D for equipment management
  • Execute assigned aspects of the project, as required.
  • Mentor and support Design Assurance engineers.
  • Ensure assigned areas are in a state of readiness for unannounced and planned audits.
  • Act as a design assurance representative during audits of areas of assigned responsibility.
  • Bring effective closure to non-conformances highlighted.
  • Support sustaining activities as assigned.
Requirements
  • A degree level qualification in Engineering, Science or related field is required.
  • experience and or/training in risk management, statistics and technical writing and test method validation is preferable.
  • Upwards of 5 years’ relevant experience in the medical device or pharmaceutical industry, preferably with Stent and Stent Coating technology experience.
  • An understanding of ISO13485, ISO14971 and FDA QSRs
  • Familiarity with statistics, validation and physical testing is required.
  • Good communication and organizational skills,
  • The ability to present reports neatly and accurately is essential.
Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies.

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