Process Development Engineer II

Process Development Engineer IIDevelop, implement, and maintain processes for medical device product manufacturing based on product specifications and in consideration to process and test method capabilities. Design fixtures and tools using computer-aided design (CAD) software tools, including SolidWorks or related. Calculate and organize all data for complex process flow sheets including instrumentation and control considerations. Identify Key Process inputs and outputs for process characterization. Model processes and unit operations. Develop processes based on product specifications and in consideration to process and test method capabilities. Conduct studies and perform statistical analyses using Minitab or related statistical software packages. Analyze statistics related to production efficiency, safety measures, and resource utilization. Ensure proper sequence of operation and prepare specifications and operating instructions for processing equipment. Provide technical information concerning manufacturing or processing techniques, materials properties, and process (advantages/limitations) engineering planning. Design and evaluate comprehensive plans for implementing manufacturing equipment, technology, and resources. Evaluate process and propose design alternatives based on Design for Manufacturability (DFM) principles. Conduct tests and measurements throughout stages of production to determine control over such variables as temperature, density, pressure and viscosity. Author and execute Process Validations including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ). Maintain knowledge of new developments in manufacturing and design technologies. Applying understanding of work environment issues (i.e. OSHA regulations, etc.). Service and troubleshoot process equipment and solve engineering problems with processes or equipment in operation using statistical tools. May supporting Corrective and Preventive Actions (CAPAs) and investigation management. Work in SAP or other ERP systems to implement manufacturing changes. Work cross-functionally with R&D, Quality and Regulatory functions to develop and implement new processes. Maintain and improve manufacturing through process development. Ensure process and procedures are compliant with medical device manufacturing regulations per FDA 21 CFR 820 and ISO 13485.Bachelor's or foreign equivalent degree in Mechanical Engineering, Industrial Engineering, or in a related engineering field of study with at least 2 years of professional manufacturing or engineering experience. Must possess an academic or industrial background in the following: (i) using computer-aided design (CAD) software tools, including SolidWorks or related; (ii) Process Validations including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ); and (iii) troubleshooting process equipment and solving engineering problems with process or equipment in operation using statistical tools; (iv) ensuring process and procedures are in compliance with FDA 21 CFR; (v) developing processes based on product specifications and in consideration to process and test method capabilities; (vi) designing and evaluating comprehensive plans for implementing manufacturing equipment, technology, and resources; (vii) analyzing statistics related to production efficiency, safety measures, and resource utilization; and (viii) maintaining and improving manufacturing through process development.An EOE. 40 hrs/wk. $81,286 - $120,000/year.