Senior R&D Process Engineer
Responsible for providing mechanical engineering support in the creation and the development of new medical device products (invasive and non-invasive). Interfaces with Design, Quality and Manufacturing organizations to integrate new products, equipment sets or processes into production.

Responsibilities:

• Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
• Conducts feasibility studies to verify capability and functionality.
• Develops new concepts from initial design to market release.
• Write and submit intellectual property (patents).
• Maintains detailed documentation throughout all phases of development.
• Working as part of the Process Development group this person will aid design of new equipment for new products & manufacturing. This person will play a key role in the design phase of the equipment from initialisation to final handover.
• Work closely with machine Vendors in order to ensure that the equipment is designed, built & tested according to specifications and is properly handed over to manufacturing.
• Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
• Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
• Plans, organizes, and conducts all aspects of technical reviews.
• Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM's, Routers, FMEA's, etc.).
• Reviews or coordinates vendor activities to support development.
• Demonstrates strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.
• Demonstrates strong knowledge and application of Process and equipment validation techniques (IQ, OQ, PQ), PFMEA's, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.
• Co-ordinates execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.
• Demonstrates a primary commitment to patient safety and product quality.
• Understands and complies with all the regulations governing the quality systems.
• Experience with low-pressure dispense systems and injection moulding an advantage.

Qualifications/Experience:

• Hons bachelors degree engineering degree qualification
• 5 yrs engineering experience in a GMP environment

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