We’re currently recruiting for an exciting opportunity with an award winning Medical Device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
The successful candidate will be a key member of the NPI Engineering project team to develop, qualify & launch a manufacturing process capable of repeatedly making new products to safety, quality, service and cost standards.
1.Design, develop and source tools, fixtures, gauges and special equipment for manufacturing processes. Co-ordinate with internal and external partners.
2. Lead NPI development requirements and work with cross functional teams in the Innovation Centre and with the Value Streams.
3. Provide design for manufacturing technical input to global design groups to minimise lifecycle cost
4. Project planning to deliver project(s) against agreed milestones and project scope (schedule, resource, cost).
5. Deliver stable manufacturing solutions in line with stability metrics process.
6. Management of R&D test parts and sample requests.
7. Conduct detailed product design reviews
8. Development of advanced manufacturing processes to lean guidelines
9. Manage risk management and validation lifecycle for new process or process changes.
10. 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).
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.
Education & Experience
1. Third level degree in Mechanical, Manufacturing, Production Engineering or similar discipline.
2. Minimum of three (3) years in product / process development, ideally in Class II / III medical devices.
3. Skilled in preparing documentation such as project plans, schedules / timelines, checklists, protocols, and reports that are often detailed and complex.
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
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480