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.
- 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.
- 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.
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