Job Title: Process Development Engineer
This range is provided by EPM Scientific. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base Pay Range
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.
* Writes and submits 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.
* Works closely with machine Vendors to ensure that the equipment is designed, built & tested according to specifications and is properly handed over to manufacturing.
* Experience with working with Laser Systems & Laser materials processing (Welding, Marking, Cutting, etc.) is an advantage.
* Knowledge in CNC code or CAD/CAM 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.
* Coordinates execution and documentation of validation builds, coordinates 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.
Seniority Level
Entry level
Employment Type
Contract
Job Function
Consulting
Industries
Medical Equipment Manufacturing
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