Engineer, Process Optimization

Position Summary 

Primarily responsible for optimizing manufacturing and operational processes, enhancing quality, supporting ERP/MES end-users, and supporting daily operations across the Operations organization, including Engineering, Production, Supply Chain, Distribution, and Facilities. This is accomplished through the analysis of data and processes, the identification of improvement opportunities, the development of optimization strategies, and the tactical execution of those strategies. This position is highly hands-on and will encompass cross functional projects across multiple departments, including Supply Chain, Manufacturing, Facilities, Distribution, IT, and QA.

Essential Duties & Responsibilities 

- Analyze existing workflows, equipment, and systems to identify bottlenecks and inefficiencies.

- Develop and revise product cost standards and routings in collaboration with applicable cross-functional counterparts (i.e. production, supply chain, quality control, finance, etc.) and maintain these in the ERP system per annual cycle 

- Assist in the development and implementation of strategies for process improvements using Lean, Six Sigma, or other methodologies (i.e. value stream mapping, 5S, Kaizen, etc.).

- Perform root cause analysis (RCA) to solve production and quality issues.

- Gather and analyze business requirements.

- Develop business and system (ERP/MES) process maps, data sets, and build report templates.

- Troubleshoot MES and ERP systems for end users and assist in correcting issues and/or escalating as needed.

- Identify areas for reducing scrap, waste, and raw material usage. 

- Optimize machine settings and workflows to increase productivity.

- Implement change management techniques to drive adoption.

- Ensure all activity is completed in full compliance with BioTissue Quality Management System and all applicable Regulatory requirements (i.e. cGMP, FDA, ISO).

- Assist operations leaders in developing and refining appropriate KPIs and metrics that support inventory, productivity, quality, safety, and delivery targets.

-Provide support for the continued rollout of full ERP and MES functionality to better manage the business.

- Develop new and improved engineering processes, including ECO/ECNs, work instruction development, BOM and routing creation and manipulation, building support documentation systems, and manufacturing interface solutions.

Skills & Abilities

Essential Duty Definition:

• Skilled in the application of lean management principles to drive improvements in manufacturing and administrative functions 
• Understanding and optimizing workflows.
• Change management skills to drive continuous improvement initiatives.
• ERP and MES knowledge.
• Strong troubleshooting skills to identify inefficiencies and propose solutions.
• Reporting skills, attention to detail, coordination of varied tasks, analytical, and tenacious.
• Proactively assesses the need for change, seeing to it that appropriate resources are available to facilitate changes, considers factors that will support or hinder change initiatives, enthusiastically promotes change in terms of the expected benefits, as well as removing or lowering the impact of potential obstacles.
• Strong communication and collaborative skills to facilitate effective project management in diverse cross-functional settings.
• Proficient in Microsoft software applications: Excel, Word, PowerPoint and Outlook.
• Thorough understanding of GTP, cGMPs, quality systems and compliance requirements.

Position Expertise/Qualifications 

• Bachelor's degree in industrial engineering or similar, required.
• 3 years ERP Systems experience, required.
• MES knowledge and experience preferred.
• 5 years process optimization/industrial engineering experience in a GMP manufacturing environment, preferred.

Physical Requirements