NPI Engineer (MedTech)
- Waterford
- Permanent
- Full-time
- Develop and refine manufacturing processes for new medical device projects.
- Manage multiple small to medium-scale projects, guiding them from concept through design for manufacture, commissioning, and qualification.
- Generate project proposals, plans, scopes of work, cost estimates, and quotations.
- Control the transfer of new product manufacturing processes to production.
- Liaise effectively with customer representatives, managing expectations regarding project progress, scope, and budget.
- Coordinate with various internal functional groups including EHS, QA, Manufacturing, Engineering, Supply Chain, Facilities/Maintenance, and Validation to ensure comprehensive project delivery.
- Track and report on project costs, schedules, targets, and achievements directly.
- Review and approve documentation, including specifications and drawings, and generate work instructions and action change notes.
- Manage internal and external teams to meet project schedules.
- Provide qualification and troubleshooting support for equipment and processes.
- Independently manage technical, engineering, and compliance matters, making decisions on engineering problems and methods.
- A minimum of 3-5 years of relevant experience in project management or research & development, ideally within a medical devices environment. We will also consider candidates from other similar regulated industries such as pharmaceuticals.
- A Bachelor's Degree (Honors) in Engineering (Level 8).
- Proficiency in MS Excel and MS Project.
- Commissioning and Validation experience, particularly with equipment and processes.
- Strong oral and written communication skills (must be able to read, write, and understand English).
- The ability to work on your own initiative and meet challenging schedules.
- A highly organized, adaptable, and flexible approach to NPI/Project Engineering.
- Initiative, creativity, resourcefulness, and the ability to work independently.
- Proficiency in a CAD package such as SolidWorks, or equivalent.
- Working experience in a manufacturing environment that is ISO 13485 certified.
- Proficiency in an MRP package such as SAP.