Job Title: Process Development Engineer
Contractor Role
Onsite
Location: Galway, Ireland
Purpose Statement:
The Process Development Engineer will collaborate closely with R&D and Manufacturing teams to develop robust, cost-effective, and safe manufacturing processes, equipment, and materials. This role ensures the efficient transfer of new products and processes into commercial production.
Key Responsibilities:
1. Technical Expertise:
* Provides strong technical leadership in process and product technologies, supporting the selection, design, optimisation, validation, and troubleshooting of these technologies.
* Mentors engineers and technicians in problem-solving and technical resolutions.
1. Collaboration with Vendors:
* Works closely with Equipment Engineering and external vendors to select, design, and develop new equipment, tooling, and materials, or upgrade existing ones.
2. Application of DFSS/DMAIC Tools:
* Utilises extensive knowledge of DFSS/DMAIC tools to characterise, optimise, and troubleshoot process equipment and technology performance.
3. Experimentation and Testing:
* Leads the planning and execution of experiments and testing to characterise, optimise, and troubleshoot key processes and equipment.
* Summarises, analyses, and draws actionable conclusions from test results to achieve effective technical solutions.
4. Process Introduction and Documentation:
* Coordinates the introduction of new processes, equipment, and materials, including installation, calibration, EHS assessments, debugging, and all necessary process and quality system documentation.
* Demonstrates expertise in Lean methodologies and process improvement tools to identify and eliminate waste, enhancing process efficiency and cost-effectiveness.
5. Validation and Compliance:
* Applies strong knowledge of process and equipment validation techniques, PFMEA, and regulatory requirements to ensure timely and efficient validation of equipment and processes.
* Leads the preparation and release of process validation documentation, including FMEAs, Validation Plans, protocols, and reports, with proficiency in IQ, OQ, PQ, and TMV.
6. Project Coordination:
* Oversees validation builds, coordinates the testing of validation units, and manages the compilation, analysis, and reporting of validation results.
7. Supervision and Development:
* Supervises one or more technicians, managing their technical development and supporting their daily tasks and project work.
8. Commitment to Quality and Safety:
* Demonstrates an unwavering commitment to patient safety and product quality, ensuring compliance with all regulations governing quality systems.
* Ensures that all direct reports understand their responsibilities regarding patient safety and product quality, are up-to-date with training, and comply with relevant regulations.
9. Quality System Requirements:
* In all actions, upholds a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
10. Supervisory Responsibilities:
* Ensures that appropriate resources (personnel, tools, etc.) are maintained to ensure Quality System compliance and adherence to the company’s Quality Policy.
* Fosters a work environment that supports the Quality Policy and Quality System.
11. Job Scope and Levelling Guidelines:
1. Functional Knowledge:
* Requires advanced conceptual and technical knowledge in the relevant job function.
* Broadens capabilities in applying job-related concepts.
12. Business Expertise:
* Demonstrates a strong understanding of industry practices and company processes to achieve objectives.
13. Leadership:
* No direct supervisory responsibilities but is accountable for personal contributions and meeting project objectives.
14. Problem Solving:
* Uses sound judgment to solve problems in straightforward situations and determines the best course of action.
* Operates under general direction from senior-level roles or a manager.
15. Impact:
* Influences the quality of personal work and the work of others on the team, adhering to established guidelines and policies.
16. Interactions and Communications:
* Clearly explains factual information to others in straightforward situations.
* Organises, presents, and explains data/information primarily to internal audiences.
Qualifications:
* Minimum Level 8 Engineering degree, with a strong preference for candidates qualified in Mechatronics and with SolidWorks experience.
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