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 Packaging Engineer (NPI) will plan and execute clean line and packaging activities to deliver the next generation of Joint Reconstruction medical devices. The role involves leading cross functional teams to develop advanced manufacturing processes for the flawless execution of new product development projects.
Collaborating with global packaging functions, the position will be responsible for ensuring optimum design for manufacturability in the introduction of new products. Implementation of leading edge technologies and innovative processes to build excellence in product and process development is expected.
The role involves collaboration with multiple disciplines within the organization. The role will interface with functions across the franchise and supply chain to ensure successful launch and stability of New Product Introductions
• Execution and project management responsibility for cleaning and packaging aspects of NPI projects.
• Manage risk management and validation lifecycle for new process or process changes.
• Management of the Asset Lifecycle for new equipment (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
• Design, develop and source tools, fixtures, clean line baskets and special equipment for clean and pack processes. Coordinate with internal and external partners.
• Provide timely and accurate reporting on project activities.
• Represent the Operations team on product development projects, communicating requirements and proposing solutions.
• Implement design for manufacturability in new product designs to minimise lifecycle cost.
• Conduct detailed product design reviews - Manufacturing technical expert to global design groups.
• Deliver stable manufacturing solutions in line with stability metrics process.
• Development of advanced manufacturing processes to lean guidelines.
• Full budget responsibility for project capital and expense spend.
• Develop strategic collaborations across functions, business units and geographic boundaries to achieve effective outcomes over the long-term.
• All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.
Education & Experience
• A minimum of a Bachelor’s degree in Engineering is required. A Masters or PhD is an advantage.
• A minimum of 3 years of experience in a general engineering role is required.
• Excellent verbal and written communication skills
• Strong decision making and problem solving skills
• 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.
• Self-motivated, with focus on Quality, Timelines and Cost.
• Experience using proven problem solving techniques (8D, TRIZ or equivalent)
• Proven experience in Root Cause analysis techniques and problem solving (8D, TRIZ or equivalent).
• Excellent Planning & Organizing Skills
• Previous experience in a packaging role in medical devices or a regulated industry.
• Certified Six Sigma qualifications.
• Expert knowledge of lean manufacturing processes.
• Proficiency of GD&T and ASME Y14.5M 1994 standards.
• Certified project management qualifications.