A permanent opportunity has arisen with a medical device SME just outside Galway city. They are looking for a Senior NPI Engineer to join their growing team. The Senior NPI Engineer will play an integral part within the team, acting in a leadership role to guide the NPI team through a range of introductions and projects.
- Lead a dedicated group of Engineers and Technicians within the New Product Introduction Group.
- Coach and mentor members of the NPI and PD team during the introduction of large-scale projects.
- Oversee and manage New Part Introduction in conjunction with the Manufacturing Group.
- Lead and manage the execution of the following NPI and PD activities:
- Supporting the Introduction of ISO56000, Innovation Management Standard.
- Execution of projects.
- Design & Development of New Products through the Customers design process.
- Prototyping and Testing concept and initial Engineering builds.
- Design Verification and Validation including development of test protocols & and reports.
- Risk Assessment and Risk Management as per ISO13485.
- Identify the requirements for new Technologies to support robust products and processes.
- Test Method & Process Development using statistical tools (R&R, DOE, Equivalence Tests).
- Clearly defined processes documented in standard work instructions.
- Process Verification and Validation for release of products for commercialisation.
- Leads and promotes a methodical and systematic Problem-Solving approach.
- Project Management and Execution of assigned projects spanning from concept to commercialisations including budgeting, prioritisation, resource management, status/stakeholder management and external communication
- Scope & define new Technology User Requirements required to support the implementation of new projects.
- Highly Effective and articulate communication skills with an ability to convey and link with people at all levels of the organisation
- Ability to work across a number of different projects simultaneously
- Ability to work cross functionally and interact with different functions across the group
- Demonstrates a behaviour of high performance and creates an environment of high engagement within the NPI Team.
- Project Management of NPI & PD projects using appropriate methods and tools. (e.g. PMBOK, Agile PM Methods)
- Six Sigma – lead problem solving and process improvement projects of medium to high complexity.
- Proficient and proven experience of Product and Process Validation.
- NFQ Level 8 or higher in a Technical Discipline (Mechanical, Manufacturing, Mechatronics or Bio-Medical) is preferred, with 5+ years Medical Device Experience.
- Project Management and/or Six Sigma Qualification – Highly Desirable.
- Process experience in Grinding, Moulding, EDM and/or Laser processes – Distinct Advantage.
For a more detailed and confidential discussion on this role contact Amy Newell.