The NPI Engineer will support the manufacturing of a cutting edge structural heart device through design development, verification, clinical trials, validation and regulatory approval. This role will provide technical engineering leadership to meet objectives in new product introduction, product commercialization and supplier projects. This position offers the opportunity to join an exciting early stage company.
Role and responsibilities:
- Working as a part of a cross functional team to update and control the manufacturing environment and processes for production of a novel transcatheter heart repair device in line with specifications.
- Planning, implementing and co-ordination of manufacturing to include: specifications, process development, training, production instructions, material specifications and procurement. Utilisation of tools as appropriate to track and communicate build plans.
- Develop and update documentation relating to equipment or processes to manufacture the device in a controlled manner in line with Regulatory standards, e.g specifications, BOM, DHR, DMR, validation documents, etc.
- Developing and executing DOEs to characterise impact of process parameter to develop robust techniques.
- Development of manufacturing processes in conjunction with R&D including, as required, training of technicians and process operators.
- Sourcing and implementing tooling, equipment and technologies, as required to implement the manufacture of the device.
- Work with contract manufacturer to implement appropriate production / assembly processes and layouts for manufacture of delivery system, including support for key builds for verifications and validation activities.
- Adhere to GMP best practices based Quality Systems requirements for medical devices including ISO 13485
- Process development and characterisation including pFMEA - both internal and with key suppliers.
- Work with R&D team to specify packaging and manufacturing consumables, e.g. sutures.
- Work within cross functional teams to assess and qualify suppliers to ensure a robust supply chain.
- Ensure product quality requirements are met both internally and throughout the supply chain during product manufacturing.
- Support quality related activities for device manufacturing ensuring controls are implemented and maintained (inspection standards, plans, frequencies and test methods, CAPA and NCR resolutions).
- Ensuring adherence to all organisational and external regulatory requirements.
- Degree or masters degree in engineering, or related disciplines
- Minimum of four (4) years of medical device experience in new product introduction, manufacturing, quality or project engineering, preferably in cardiovascular devices.
- Project management skills - capable of operating and liaison at all levels including managerial, project and technical.
- Broad knowledge of materials and manufacturing processes applicable to medical device industry is desirable.
- Ability to manage self and others to achieve challenging targets
- Demonstrated analytical problem-solving abilities to resolve complex technical issues
- Class III medical product development experience preferred
- Working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
- Experience of preparing technical documentation
- Excellent communication, organisational and time management skills
- Flexibility to travel to vendor sites to support service and project activities.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.