Process Engineer

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.
• To deliver NPI projects through the product management team, by providing engineering support and expertise to achieve high quality and on-time launches.
• To deliver equipment transfer, product transfer and process transfer within the same Operating companies and from external suppliers.
• To provide Engineering support and actively drive 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.
• 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.
• To draft and review the complete process qualification and risk management documents.
• To ensure that the additive process meets all corporate and regulatory requirements for Quality, Health, Safety and Environment.
• To ensure 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.

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