Senior Packaging Engineer

Job Description

Senior Packaging Engineer to join the Advanced Engineering team in a industry leading Medical Device manufacturer in Cork

OUTLINE:

The Snr. Packaging Engineer will plan and execute packaging activities to deliver the next generation of Joint Reconstruction medical devices.

• 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.
• Collaboration with multiple disciplines within the organization.
• Interface with functions across the franchise and supply chain to ensure successful launch and stability of New Product Introductions.

On a daily basis your work in NPI will interact with H&S, Quality, Operations, Product Design and global packaging teams to develop this process to market launch. You will own either a process step in a project or a process technology for multiple projects. The project team will develop, qualify & launch a manufacturing process capable of making implants to safety, quality, service and cost standards.

RESPONSIBILITIES

• Execution and project management responsibility for 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).
• Conduct engineering studies to ensure compliance
• 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 and special equipment for pack processes. Co-ordinate with internal and external partners.
• Planning of key deliverables into action plans & 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 minimize 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.
• All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.
• Participate in DFM reviews with Design Team to minimize lifecycle cost
• Minimize Environmental and Health & Safety effects of your work
• Adhere to the company's procedures as detailed in the SOP manual
• Support Regulatory Affairs with product submissions
• All other duties as directed by direct manager

EXPERIENCE / QUALIFICATIONS

ESSENTIAL CRITERIA:

• A minimum of a Bachelor's degree in Engineering is required.
• Minimum 3 years validation experience
• 3-5 years' experience in Medical Devices or regulated industry and exhibiting evidence of GDP and technical writing (drafting & routing documents i.e. validation protocols, reports, engineering studies, risk assessments, change control & procedures)
• Self-motivated, with focus on Quality, Delivery and Cost
• Must be accustomed to fast-paced, high-pressure environment.

DESIRABLE CRITERIA:

• Relevant packaging technology and materials experience
• Exposure to Project Management & New Product Introduction
• Root Cause analysis and problem-solving techniques & Six Sigma qualifications.
• Knowledge of lean manufacturing processes.
• Provide timely and accurate reporting on project activities

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.