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:

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.

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.

Application of DFSS/DMAIC Tools:

• Utilises extensive knowledge of DFSS/DMAIC tools to characterise, optimise, and troubleshoot process equipment and technology performance.

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.

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.

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.

Project Coordination:

• Oversees validation builds, coordinates the testing of validation units, and manages the compilation, analysis, and reporting of validation results.

Supervision and Development:

• Supervises one or more technicians, managing their technical development and supporting their daily tasks and project work.

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.

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.

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.

Job Scope and Levelling Guidelines:

Functional Knowledge:

• Requires advanced conceptual and technical knowledge in the relevant job function.
• Broadens capabilities in applying job-related concepts.

Business Expertise:

• Demonstrates a strong understanding of industry practices and company processes to achieve objectives.

Leadership:

• No direct supervisory responsibilities but is accountable for personal contributions and meeting project objectives.

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.

Impact:

• Influences the quality of personal work and the work of others on the team, adhering to established guidelines and policies.

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.

Community and Quality of Life in Galway:
Experience the vibrant culture, friendly community, and exceptional quality of life that Galway, Ireland, has to offer—one of Europe's most charming cities with a perfect blend of urban amenities and natural beauty.

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/   

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