We’re currently recruiting for an exciting opportunity with an award winning medical device organization based in Cork. This is an excellent opening for anyone who is looking to join a leading multinational who are one of the best at what they do.
Development and installation of manufacturing processes and for new product introductions. The successful candidate will provide the technical lead in cross functional teams to set up new processes to meet challenging project commitments in line with agreed stability metrics. The role will involve collaborating with global R&D teams to develop innovative and cost effective devices and delivering highly stable and effective manufacturing processes.
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. Management of the Asset Lifecycle for new equipment (URS/RA/IQ/OQ/PQ).
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.
• Obtained as a minimum a Degree in Mechanical/Production/Manufacturing Engineering and experience in a medical device or comparable hi-tech environment.
• Proven track record in development, Installation and qualification of manufacturing processes for New Products or Product Transfer.
• Experience using proven problem solving/Root techniques (8D, TRIZ or equivalent)
• Demonstrated ability to lead sub teams within a project and give direction to fellow team members, contractors, vendors to complete tasks to a defined timeline.
• Skilled in preparing documentation such as project plans, schedules / timelines, checklists, protocols, and reports that are often detailed and complex.
• Self motivated, with focus on Quality, Timelines and Cost.
• Proficiency of GD&T and ASME Y14.5M 1994 standards
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. Knowledge of anatomy and physiology.
4. Knowledge of manufacturing processes.
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480