Our Client, a leading medical device company in Ireland, is looking for a Senior Packaging Engineer to join their team.
Successful candidate will independently determine and develop approaches to a variety of technical problems of moderate scope and complexity relating to packaging process and design. He uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
Key Areas of Responsibility
- Provide engineering support for the packaging of new product and process introductions, ensuring that all activities are completed and documented in accordance with the new product development procedures.
- Support and execute validation activities for packaging equipment and materials.
- Support packaging suppliers for new product packaging development and qualification.
- Provide technical support to packaging operations to troubleshoot, investigate, and recommend solutions to package quality issues.
- Provide packaging process technical support to Packaging Design team, in developing packaging solutions for new products or product transfers.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Will select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
- May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
- Will analyse equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
- Participate in PFMEA, Control Plan, SOP and PPAP generation associated with packaging for product transfers and launches.
- Complete capability studies for in process inspection and generate subsequent Inspection documentation.
- Conduct MSA studies for new products and new processes.
- B.S in Mechanical Engineering or related engineering discipline with 4 or more years’ experience in Medical Device or Pharmaceutical packaging, or a related master’s degree.
- Proven track record of working in a team-based environment.
- Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.
- Excellent analytical skills, ability to plan, organise and implement concurrent tasks.
- Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
- Certified in validation activities.
- Experience in an FDA regulated or regulated industry beneficial.