Senior Process Development Engineer – Galway (Perm)

Senior Process Development Engineer –  Galway (Permanent)

CREGG are now recruiting for a Senior Process Development Engineer.
This is a fantastic opportunity to join a world leading Medical Device company in Co. Galway as a Senior Process Development Engineer, with great career opportunities in a dynamic working environment.  

Works cross-functionally to lead the development of robust, capable, cost effective & safe Extrusion, Balloons & Moulding processes, equipment, materials and products and ensures efficient and effective transfer of new products & processes into commercial production.

• Provides Technical Leadership to Engineers and technicians within own team and to wider Stakeholders to provide direction on optimum solution(s) to the Process Development of new Moulded, Extruded and Balloons Components. 
• Provide scientific understanding and technical engineering skills to meet business goals and objectives.  Ability to coach, lead and enhance the productivity of technical reports within the business.   Provide a structured framework for training of technical reports.  Build collaborative relationships through strong teamwork across the organization.
• Initiates cross-functional partnerships to identify and resolve process related issues.
• Liaises with other relevant functions with regard to ongoing development of current processes and systems and future development needs.
• Project planning, in detail, in support of major projects, product/process development etc.
• Provides Technical Leadership in the selection, design, optimisation, validation and troubleshooting, of key processes & product technologies.
• Leads the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of key processes and equipment.  Summarises, analyses and draws conclusions from test results leading to effective technical resolution.
• Faciliitates the use of Six Sigma & Problem Solving tools leading a team of engineers and technicians in the characterization, optimization and troubleshoooting of process equipment and technology performance.
• Liases with Equipment Engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.
• Prioritizes and drives execution of multiple complex projects. Sponsors and supports team initiatives where required.
• Co-ordinates the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.
• Demonstrates strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of “waste” process steps  and development of efficient, cost effective equipment and processes.
• Demonstrates strong knowledge and application of Process and equipment validation techniques, PFMEA’s/PRA's and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.
• Leads the writing and release of process validation documentation including PFMEA/PRAs, Validation Plans, protocols and reports.
• Leads execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.
• Supervision of one or more Engineers or Technicians, managing their technical development and facilitating their daily and project tasks.
• Demonstrates a primary commitment to patient safety and product quality.
• Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
• Understands  and complies  with all the regulations governing the quality systems.

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

• May Guide, coach, direct a group or team of employees in the achievement of goals.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitor and ensure compliance with company policies and procedures.

Requirements 

A seasoned, experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field.

Has a minimum of 5 years experience in Polymer component Manufacture in a Medical Device Industry.

Ideally is Qualified in Polymer Engineering/Science or equivalent (Level 8 or higher).

General knowledge of other related disciplines, business unit function and cross group dependencies/relationships. This job is the fully-qualified career-oriented position.

For more details about this role get in touch – Contact:
Gary Keane
garykeane@cregg.ie
061-363318