- Reference: GY45840AO
- Job Type: Permanent
- Location: Galway
- Category: Engineering, Technical & Manufacturing
We are currently looking for a Senior Process Development Engineer to join our team. This position requires the candidate to have a proven track record in managing and delivering complex projects with significant technical challenges. Overall responsibility for various projects, including process development, design development, implementation of new equipment/automation and new product introduction.
- Develop and enhance manufacturing processes by implementing Lean and Six-Sigma methodologies to maintain process control and stability.
- Coordinate, plan and manage the transfer of New Product Introductions (NPI) and technology transfer programs and to ensure strict adherence to project timelines.
- Introduction of manufacturing equipment and fixturing. To take ownership from initial supplier selection right through to installation and validation of equipment/processes.
- Create and maintain manufacturing and procedural documentation, including technical drawings, equipment specifications, User Requirements Specifications (URS), and Factory Acceptance Test (FAT) documents.
- Development of specifications for assessing the performance of the new processes.
- Ensure the timely and successful completion of process-based projects in accordance with the needs of the business.
- To provide technical support to R&D during product development to allow for smooth transition of new products in to the manufacturing environment.
- To actively engage in providing engineering support and technical training to the manufacturing group.
- Assist in the recruitment and training of new personnel to support organisation growth.
- Creation of engineering protocols and reports associated with test method development, the acquisition of new equipment, validation of processes and equipment.
- Assist in the Sourcing, approval and the Auditing of vendors.
- Lead IQ validation activities with regards to the introduction of new equipment. Also, take the lead with respect to commercialisation of product development projects in terms of executing OQ, PQ and PPQ activities.
- Lead process change activities so that upgrades are implemented in an efficient quality-focussed manner.
- Serve as point of contact between Process Development and Quality departments in terms of planning the introduction of new equipment, upgrading current systems, implementing process changes, etc.
Behaviours & Skills required include Strong technical ability based on a broad and deep knowledge of fundamental engineering principles. Strong work ethic, creative problem solving, capable of working on own initiative. Excellent writing, presentation, and verbal communication skills essential.
Qualifications & Experience: Primary and/or a postgraduate degree BS, MS, or PhD (mechanical, Materials, Polymer, or Biomedical Engineering, or related technical field). Minimum 5 years Process Development and new product introduction experience in Medical Device Manufacturing.
For a confidential discussion and more information on the role/company please email your CV to: firstname.lastname@example.org