The Role
The Process Engineer will play a crucial role in the development and optimization of manufacturing
processes for the customer Network Transfer project. The primary objective is to ensure the
production of high-quality medical devices while enhancing efficiency, reducing costs, and ensuring
compliance with regulatory standards. This position involves collaborating with cross-functional
teams to implement process improvements, adhere to industry regulations, and support process
development initiatives.
Key responsibilities:
• To provide Engineering support in the development and optimization of manufacturing
solutions for the New Product Introduction process.
• Conduct process validations and ensure compliance with FDA and ISO regulations.
• Draft and execute IQ, OQ, PQ in cleanroom environment.
• 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,
meet all corporate and regulatory requirements: to include required project documentation
including risk assessments / process FMEA’s etc.
• Adherence to departmental policies and procedures in line with the company’s quality
systems and standards.
• Representing Engineering, within project core teams throughout the organisation
• To carry out such further tasks that may be delegated by immediate management.
• Conduct root cause analysis and implement corrective actions for process deviations.

Your Profile

TCS Confidential | 2

Essential skills/knowledge/experience:
• Experience in CNC Machining/CAM Programming
• Experience in process engineering within the medical device or related industry. In hand
experience CNC machining is a plus.
• Proven track record of successfully implementing process improvements and
optimization.
• Experience with process validation and regulatory compliance in a MedTech
environment.
• Familiarity with project management principles and experience leading cross-functional
projects.
• Experience in Creating Manufacturing routes and BOMs
• Experience in Creating detailed process flows
• Knowledge of fixture and tooling design
• Knowledge of the processes and equipment used in implant and instrument manufacturing
• Good understanding of the design process and tools used
• Experience in DFMEA, PFMEA, 6 sigma and Lean
• Experience of working with GMP (Good Manufacturing Practice).
• Experience in project management and problem solving
• Knowledge of quality systems, regulatory requirements and related standards, with
demonstrated understanding of the practical application of these requirements
• Excellent planning and organizational skills
• Ability to build effective relationships and networks locally/globally
• Make complex issues clear and transparent
• Ability to effectively influence, negotiate and use conflict resolution skills
• Good written and verbal communication skills.
• Effective communication skills with the ability to work in cross-functional teams.