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Engineering & Technical

Job Description

An NPI Packaging / Project Engineer is required on a 12 month contract basis by CareerWise Recruitment for our Cork based Medical Device Client. The Packaging / Project Engineer (NPI) will plan and execute 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 NPIs. 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 and launch a manufacturing process capable of making implants to safety, quality, service and cost standards.

Role of this position

  • 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 and 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
  • Participate in DFM reviews with Design Team to minimize lifecycle cost
  • Support Regulatory Affairs with product submissions

JOB REQUIREMENTS

ESSENTIAL CRITERIA:
  • A minimum of a Bachelor's degree in Engineering is required. A Masters or PhD is an advantage
  • Demonstrated validation experience/ exposure
  • 1-3 years' experience in Medical Devices or regulated industry and exhibiting evidence of GDP and technical writing
  • 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 and New Product Introduction
  • Root Cause analysis and problem-solving techniques and Six Sigma qualifications
  • Knowledge of lean manufacturing processes
  • Provide timely and accurate reporting on project activities
  • Excellent verbal and written communication skills
  • Excellent Planning and Organizing Skills

Please call Aisling O'Hagan-Yil today for further information on 021- 2427410 or email:
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

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Engineering & Technical

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie