Process Engineer in Leeds

Duties & Responsibilities

• Participates in comprehensive engineering activities to develop and implement effective, high-quality processes and design guidelines for dissemination throughout the division.
• Provides feedback for design reviews and improvements in manufacturability.
• Implements equipment, materials, and process performance requirements and performs vendor searches and equipment evaluation to ensure adequate capacity to produce quality products in required quantities at an effective cost.
• Facilitates experiments and capability studies, develops process specifications and designs and procures process tools.
• Evaluates and advises on the selection of suitable equipment for optimised, balanced line performance.
• Processes analyses of new systems and equipment with the intention of achieving continuous improvement of present methods.
• Edits and publishes process documentation and training materials for processes, materials, and equipment.
• Delivers NPI projects through the product management team, by providing engineering support and expertise to achieve high quality and on-time launches.
• Delivers equipment transfer, product transfer and process transfer within the same Operating companies and from external suppliers.
• Provides Engineering support and actively drives the development and optimisation of manufacturing solutions to include but not be limited to: Process Planning / Methods Engineering; Creation of Detailed Manufacturing Routes; Computer‑Aided Manufacture (CNC); Computer‑Aided Manufacture (CAM); Continuous improvement.
• Drafts and reviews the complete process qualification and risk management documents.
• Ensures that the additive process meets all corporate and regulatory requirements for Quality, Health, Safety and Environment.
• Ensures all manufacturing solutions and manufacturing‑related documentation is accurate, meets all corporate and regulatory requirements: to include required project documentation including risk assessments / process FMEAs etc.

Quality And Compliance Related Responsibilities

• Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations.
• Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.

Job Specific Competencies

• Experience of working with GMP (Good Manufacturing Practice).
• Computer literacy especially with respect to office‑based tools including MS Project, Word, Excel, Visio, Mini Tab.
• Experience of validation within a regulated environment (ISO 9001/2000, FDA QSR regulations).
• Process Excellence / Six Sigma type environment. (Black/Green Belt) desirable.
• Good knowledge of the processes and equipment used in medical devices (implant and instrument) manufacturing.
• Good knowledge of the fixture design.
• Hands on NX.
• Good understanding of the design process and tools used.
• Good knowledge of CAD/CAM/CMM desirable.
• Good experience in FEA, DFMEA, PFMEA, Six Sigma and Lean.
• Good experience in project management and problem‑solving.
• Good knowledge of quality systems, regulatory requirements and related standards, with demonstrated understanding of the practical application of these requirements.

Education

• Technical degree in a related discipline (Engineering / Science).

Experience

• Ideally 3+ years’ experience in process and machine development desirable.
• Good experience in devising, implementing, monitoring and managing project plans.
• Proven and clear understanding of project delivery.
• Experience in design and CAM programming using UG preferable.