Job Title: Project Engineer, NPI
Department : Innovation Centre – New Product Introduction
Reports to: Engineering Team Leader
Key member of an NPI Engineering project team at the Cork Innovation Centre, to develop, qualify & launch a manufacturing process capable of repeatedly making new products to safety, quality, service and cost standards.
1. Planning and execution of verification and validation activities, including:
• Generation of Validation Protocols and Reports.
• Execution of Equipment Validations (IQs/OQs) and subsequently Process Validation (OQ / PQs).
2. Lead NPI development requirements and work with cross functional teams in the Innovation Centre .
3. Provide design for manufacturing technical input to global design groups to minimise lifecycle cost.
4. Design, develop and source tools, fixtures, gauges and special equipment for manufacturing processes. Co-ordinate with internal and external partners.
5. Project planning to deliver project(s) against agreed milestones and project scope (schedule, resource, cost).
6. Deliver stable manufacturing solutions in line with stability metrics process.
7. Management of R&D test parts and sample requests.
8. Conduct detailed product design reviews
9. Development of advanced manufacturing processes to lean guidelines
10. Manage risk management and validation lifecycle for new process or process changes.
11. Direct PFMEA studies and lead risk assessment effort for overall process
12. Influence innovative qualification methodologies to apply appropriate statistical and validation techniques based on failure model and overall risk
13. Develop strategic collaborations across functions, business units and geographic boundaries to achieve effective outcomes over the long-term.
14. Provide timely and accurate reporting on project activities.
1. Third level degree in Mechanical, Manufacturing, Production Engineering or similar discipline.
2. Experience in product / process development, ideally in Class II / III medical devices.
3. Strong interpersonal and team skills with ability to collaborate effectively and demonstrate conflict resolution.
Solid planning and organization skills including attention to detail, multi-tasking, critical thinking and problem-solving skills.
4. Skilled in preparing documentation such as Validation protocols and reports, process documentation, project plans, schedules / timelines and checklists that are often detailed and complex.
5. Flexible work ethic.
1. Certification from an accredited institution in Project/Program Management.
2. Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820) and other pertinent Design Control requirements.
3. Proficiency of GD&T and ASME Y14.5M 1994 standards
4. Knowledge of anatomy and physiology.
5. Knowledge of manufacturing processes.