Description
Responsibilities
Qualifications/Experience:
- 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 Boston Scientific specifications and is properly handed over to manufacturing.
- Experience with working with Laser Systems & Laser materials processing (Welding, Marking, Cutting, etc) an advantage.
- Knowledge in CNC code or CADCAM would be beneficial.
- 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 metal additive and/or 3D printing is beneficial.
Qualifications/Experience:
- Level 8 engineering degree qualification
- 5+ yrs engineering experience in a GMP environment