Senior (Sustaining) Design Assurance Engineer
Reporting to the Design Assurance Manager, the sustaining design assurance engineer will work predominantly as part of the sustaining team. On occasion the sustaining design assurance engineer will support new development projects to introduce or improve products for treatment of a range of diseases. The sustaining Design Assurance Engineer will collaborate with operations, quality assurance, R&D and regulatory affairs to support the Company’s commercialisation strategy.
- Work within the quality system to ensure that the quality policy and company systems and procedures are complied with
- Support the development / evolution of the Design Control, Risk Management and associated systems, to encompass sustaining activities.
- Provide Design Assurance input to commercial activities:
- Understand the regulatory requirements for device development, specifically device changes and providing input to encompass these
- Lead the design verification and design validation assessment of design changes.
- Maintain the Design History File for commercialised devices and associated documents.
- Lead the risk management activities for designated sustaining projects, design changes, complaints and CAPAs.
- Develop and maintain design verification and validation plans, protocols, and reports for design changes.
- Support the project DA engineer(s) in the preparation and delivery of
- Design Transfer to Commercial Reviews and associated checklists.
- Support the execution of non-clinical studies at third party facilities, in conjunction with R&D department.
- Provide DA support to R&D for equipment management.
- Execute assigned aspects of the project, as required.
- Co-ordinate the annual risk management review for commercialised devices
- Execute gap analysis to standards, ASTMs and other associated documents.
- Support Activities: Act as a design assurance representative during audits of areas of assigned responsibility.
- Support R&D, RA and Project Design Assurance in development activities.
- 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 industry, preferably with Stent or class III device design assurance experience.
- An understanding of ISO 13485, ISO 14971 and FDA QSRs
- Familiarity with statistics, validation and physical testing is required.
- Good communication, 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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