Department: Quality Assurance
Reporting: QA/RA Manager
The Design Assurance Engineer is an integral part of the product development team who is responsible for implementing and promoting best in class design assurance through the product lifecycle for Neurent Medical devices. The Design Assurance Engineer ensures that R&D projects are executed in accordance with industry standards and that appropriate product verification and validation activities are implemented to support marketing applications for the device(s). The role requires a minimum of 3 years’ experience in the medical device industry and the candidate must have experience and knowledge with bringing products through regulated design control processes through design verification and validation activities through to regulatory submission and commercialisation. As a member of a growing team the Design Assurance Engineer must be flexible and willing to carrying out tasks outside of their routine responsibilities.
DUTIES & RESPONSIBILITIES
The role of the Design Assurance Engineer includes but is not limited to the following responsibilities and skill sets:
- Work within the Quality System ensuring that the quality policy and company systems and procedures are complied with, in line with FDA Quality Systems Regulations, ISO 13485, ISO14971 and all relevant standards.
- Support the development / evolution of the Neurent Medical Design Control System, Risk Management System, Design Change System, and all associated systems, to encompass new product development technologies.
- Be an integral part of R&D project teams, to ensure that
- R&D projects are executed in accordance with internal practices and industry and product standards.
- Design verification and validation activities are executed to the highest standards including plan and protocol development, managing activities with external service providers, report writing, design assurance program management.
- Risk management activities are conducted in accordance with industry best practices and the risk management file is maintained in accordance with internal procedures and ISO14971.
- Test methods are appropriately developed and validated.
- Support R&D in the preparation and delivery of Design Reviews and associated checklists.
- Establish and maintain the Design History File and associated documents.
- Provides design quality support in the resolution of complaints investigation, CAPAs, regulatory requirement changes.
- Conduct education and training with team members to ensure that best-in-class levels of compliance are maintained.
- Keep up to date on best practices and constantly seek to improve compliance and efficiencies in line with best practices
- Degree in Engineering/Science or related discipline.
- Minimum 3 years experience in a relevant role in the medical device industry,
- Experienced with ISO14971 Risk Management Systems,
- Advanced knowledge and experience with medical device regulated design control systems including advanced knowledge of design verification and validation methods.
- Highly developed written and verbal communication skills
- Proven ability of working in a cross-functional team environment,
- Knowledge and practical experience with the use of statistical techniques in design verification and validation,
- Training and experience in auditing (internal auditing, supplier auditing or similar),
- Strong communication and presentation skills are desirable
- Thinks Critically and Makes Sound Decisions
- Collaborates and Creates Alignment as a Team member
- Works with transparency