We are currently supporting one of our key clients as they look to add an NPI Engineer to their team. The NPI Engineer will lead the execution of Product Development activities within an exciting and growing team. This role is with a progressive, medium sized medical device company who just recently announced an expansion and will therefore offer any experienced NPI Engineer excellent opportunity and career growth potential
· Lead 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.
· 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.
· NFQ Level 8 or higher in a Technical Discipline (Mechanical, Manufacturing, Mechatronics or Bio-Medical) is preferred, with 3 - 4 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.
· Highly Effective and articulate communication skills with an ability to convey and link with people at all levels of the organisation.
· An ability to work cross functionally as this role requires interaction 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.
For a more detailed and confidential discussion on this role contact Amy Newell.