Job Description

Responsibilities arrow_right

• Work collaboratively with engineers and customers to design and develop silicone extrusion and molding processes using existing and innovative technologies.
• Develop equipment and process validation protocols and reports (IQ, OQ, PQ) in accordance with applicable corporate procedures and in conjunction with senior engineers and the customer project team.
• Specify new and existing product processes at a high level through the creation of process flowcharts and diagrams.
• Create and/or update bills of materials, manufacturing procedures, and recipes for components, assemblies, packaging, labeling, and other documents needed for the device master record.
• Specify required machinery, fixtures, gauges, and other equipment needed for the verification and manufacture of medical devices.
• Work with internal resources to design and execute equipment validations in a cleanroom environment.
• Design or aid in the modification of extrusion and molding processing tooling.
• Train technicians and manufacturing associates on manufacturing processes in conjunction with the operations team through product launch and subsequent sustaining engineering actions.
• Develop test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
• Ensure developed processes meet or exceed the required cycle time to meet initial production forecast and cost. Create DOEs to characterize and/or improve processes.
• Initiate improvements in new and existing processes to improve part quality/yields, cycle times, and to reduce cost, using LEAN manufacturing and/or Six Sigma skills.
• Investigate and/or create DCR (Document Change Request), disposition material, develop and implement process changes and proper documentation of any such changes.
• Regular attendance at LPMS (Lean Production Management System) meetings to provide communication and technical support to support daily production requirements and NPI projects.
• Schedule runs with Operations and/or Customer Service to ensure adherence to project timelines.
• Maintain adherence to company policies, safety/ergonomic standards, good housekeeping. 

Qualifications arrow_right

• Bachelor of Science in Mechanical, Manufacturing, Industrial, Biomedical or other Engineering discipline. EIT a plus.
• Minimum 3 years of experience as a process, validation, or manufacturing engineer in a manufacturing environment. Medical manufacturing experience is preferred.
• Experience in silicone, plastic, or rubber extrusion or molding manufacturing preferred.
• Must possess a hands-on mechanical aptitude.
• Strong interpersonal, oral, and written communication skills with the ability to effectively communicate within the organization, and with customers and suppliers as required.
• Ability to provide accurate inputs for the preparation of project timelines and estimates.
• Proficient with use of Microsoft Office applications including Word, Excel, Visio and PowerPoint. Proficient with use of SolidWorks 3D CAD software to create solid models and engineering drawings. Able to learn and use MRP systems; SAP preferred.
• Ability to utilize metrology equipment such as pin gauges, calipers, micrometers. CMMs.
• Ability to learn and use a variety of problem solving methods to find solutions to complex engineering problems, root cause analysis, fault-tree analysis, DMAIC, 8D, 5-whys, A3. 
• Experience in a structured regulatory environment with advanced quality systems such as ISO13485, FDA CFR 21, ISO 9001, AS9100, TS16949, or equivalent preferred. 
• Certifications in LEAN manufacturing, SPC, or Six Sigma technique a plus.

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