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.
Duties
• Lead NPI development requirements and work with cross functional teams in the Innovation Centre and with the Value Streams.
• Provide design for manufacturing technical input to global design groups to minimise lifecycle cost
• Project planning to deliver project(s) against agreed milestones and project scope (schedule, resource, cost).
• Deliver stable manufacturing solutions in line with stability metrics process.
• Conduct and lead detailed product design reviews
• Development of advanced manufacturing processes to lean guidelines
• Manage risk management and validation lifecycle for new process or process changes.
• Management of the Asset Lifecycle for new equipment and processes (URS/RA/IQ/OQ/PQ).
• Direct PFMEA studies and lead risk assessment effort for overall process
• Influence innovative qualification methodologies to apply appropriate statistical and validation techniques based on failure model and overall risk
• Develop strategic collaborations across functions, business units and geographic boundaries to achieve effective outcomes over the long-term.
• Provide timely and accurate reporting on project activities.
• All other duties as directed by direct manager.
Education & Experience
• Obtained as a minimum a Degree in Mechanical/Production/Manufacturing Engineering and 3 years minimum post graduate (Ideally 5 years plus) 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)
• Certification from an accredited institution in Project/Program Management.
• Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820) and other pertinent Design Control requirements.
