Location: To be based at the Company’s offices at GMIT Innovation Centre in Galway.
The Development Engineer will lead the company’s management of outsourced manufacturing partners for prototype and pilot production builds and will work with the full team support the timely and cost-effective market release of new and updated products, whilst meeting the required quality and regulatory standards for such enteral feeding devices.
- Work with the R&D team in the design and development of novel enteral feeding delivery systems
- Contribute to ongoing product innovation
- Play strong technical leadership role in specific aspects of the various projects being worked on
- Liaise with the enteral feeding community to understand and gather specific product requirements.
- Lead the generation of improved (in terms of performance, ease of use, reliability, manufacturability, and cost) device designs
- Lead the development and refinement of device specifications, in line with user needs and design inputs. This will include the creation of detailed component and finished device assembly drawings/specifications.
- Manage outsourced manufacturing activities related to any devices being developed. This will include supporting the development of required manufacturing and test capabilities.
- Identify and manage key risks throughout the product development lifecycle.
- Identify, define, and document constraints and assumptions for the development and testing of medical devices.
- Responsible for developing and performing design verification and validation strategies, plans and execution activities to clearly defined acceptance criteria.
- Support Design Reviews with a focus on requirements definition and V&V activities.
- Support risk management activities, including FMEAs, to ensure robust and reliable designs.
- Lead, develop and implement design characterization, DOEs and design verification strategies.
- Identify and manage vendors in relation to components, processes, and equipment.
- Support the identification of device Design Verification requirements
- Develop test protocols that ensure all required information is captured as efficiently as possible
- Develop test methods and fixturing for product verification and validation; analyse and report testing performed.
- Manage and support internal prototype build activities
- Ensure all work is performed in full compliance with Quality, Regulatory, Health and Safety and other relevant legislation. This will include the completion of Design History Files, Design Inputs, Outputs, Design Reviews, Lab notebooks, etc. as necessary.
- Ensure full traceability of Design Development and control of changes.
- Provide support to Company team members, as required.
Qualifications & Skills Required
- Level 8 or higher in Design Engineering, Mechanical Engineering, Biomedical Engineering, Polymer Engineering, or a related discipline.
- 3 to 5 years of relevant experience in the medical device industry.
- Strong technical ability, with innovative outlook
- Design for X (especially Manufacture, Reliability, Sustainability and Cost) experience
- Strong technical writing skills, and good presentation skills
- Highly effective and demonstrable Project Management skills
- Ability to multi-task
- Team player who can effectively work with cross-functional groups and actively manage relationships
- Experience in the generation and progression of IP
- Experience in the development of manufacturing and test capabilities
- Experience in working with clinical KOLs on identifying user needs
- Strong understanding of the use of statistical analysis
- Experience of the use of CAD software
Applications to be emailed to email@example.com