LEAD MANUFACTURING PROCESS ENGINEER - Evalve, an Abbott Labs Co. / Westfield, IN

Provide leadership to engineering staff regarding project prioritization, process validations, continuous improvement (CI) activities, and New Product Introduction (NPI) manufacturing engineering. Lead team to maintain Key Performance Indicators (KPIs) under control. Provide prioritization and allocate engineering resources, according to business needs and understand the financial structure of the organization and its interactions with results. Use product cost knowledge to identify risks and opportunities. Conduct Design of Experiments (DOE) to characterize manufacturing processes activities. Prepare product and process reports by collecting, analyzing, and summarizing information and trends. Writing and executing installation and process validation activities, including Test Method Validations (TMV), Installation Qualification, Operational Qualification, Performance Qualification (IQ/OQ/PQ) for Class II/III Medical devices manufacturing processes. Estimate validation activities cost and assure it is budgeted within financial cycle. Apply industry best practices related to equipment and process qualification. Assure manufacturing lines have equipment requirements fulfilled according to production plan. Keep equipment operational by coordinating calibration, maintenance, and repair services. Analyze equipment data, trends, and performance to assure correct lifecycle management. Use historical data to drive future equipment selection. Use statistical/data analysis software, including Minitab, JMP, and Statistical Process Control (SPC) software, to conduct statistical and data analyses, including normality assessment, k-factor, t-test, safety factor, and process capability,to facilitate decision making and draw conclusions from available data. Apply understanding of potential risks related to product malfunctions proactively. Evaluate financial, process or quality impact derived from product and process changes. Apply knowledge and expertise of product requirements and expertise to develop tooling, fixturing and automated manufacturing systems. Assure that production line output meets product specifications. Lead validation plans for products and processes and leading investigations, including root cause analyses (RCAs), troubleshooting, Non-Conformance Material Reporting (NCMR), and implementing Corrective and Preventative Actions (CAPAs). Ensure compliance with medical device manufacturing industry regulations and standards, including FDA 21 CFR Part 820, Good Manufacturing Practices (GMPs) and ISO 13485. Navigate and execute activities on manufacturing systems, such as updating routers, Bills of Materials (BOMs), or generating new part numbers and ZFINs. Coordinate activities related to new ZFIN's implementation. Support Direct Labor (DL) and Indirect Labor (IDL) training processes. Lead or support local cross functional team activities and participate in external cross functional teams (i.e. Regulatory Affairs, Quality Assurance, Research and Development, etc.) representing the manufacturing engineering function. Lead global initiatives with other functions and sites and support the team to meet quality indicators. Lead complex projects as project manager, including NPI, substantial product changes, line expansions, site transfers, etc. Identify and implement CI projects for any of the main key areas: safety, quality, production, and cost. Provide technical assistance, training, and performance management to junior personnel. Provide input for the departmental budget preparation. Six Sigma Yellow Belt, Green Belt or Black Belt certification required. Up to 20% domestic travel required.

Bachelors or foreign equivalent degree in Mechanical Engineering, Industrial Engineering, or in a closely related engineering field of study with at least 5 years of progressive professional medical device manufacturing e gineering experience in: (i) New Product Introduction (NPI) manufacturing engineering; (ii) conducting Design of Experiments (DOE) to characterize manufacturing processes; (iii) writing and executing process validations, including Test Method Validations (TMV), Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) for Class II/III Medical devices manufacturing processes; (iv) statistical/data analysis software and programming languages, including Minitab, JMP, and Statistical Process Control (SPC) software; (v) statistical and data analyses, including normality assessment, k-factor, t-test, safety factor, and process capability; (vi) developing tooling, fixturing and automated manufacturing systems; (vii) leading validation plans for products and processes and leading investigations, including root cause analyses (RCAs), troubleshooting, Non-Conformance Material Reporting (NCMR), and implementing Corrective and Preventative Actions (CAPAs); and (viii) ensuring compliance with medical device manufacturing industry regulations and standards, including FDA 21 CFR Part 820, Good Manufacturing Practices (GMPs) and ISO 13485. Position requires Six Sigma Yellow Belt, Green Belt or Black Belt certification. Up to 20% domestic travel required.

An EOE. 40 hrs/wk. Send resumes to: Abbott Laboratories, Attn: Elvia Salazar, Willis Tower, 233 South Wacker Dr. Fl.25, Dept. 32, Chicago, IL 60606. Refer to ad code: ABT-0073-ES.