Sr. Process Engineer

Position Summary The Process Engineer will continuously improve the safety, quality, and efficiency of the plant’s manufacturing processes in order to meet or exceed customer expectations. Responsible for leadership and to ensure priorities and performance are aligned with the company’s strategic direction. A technical and hands-on position requiring work in individual and team settings, contributing to all aspects of corporate efficiency and continuity. Project management, needs analysis, design review, testing, implementation, validation, and ongoing support of systems solutions. Primary Responsibilities / Essential Function Safety Ensure that new and existing manufacturing equipment modifications are designed to minimize safety hazards. Ensure that all manufacturing equipment is operated in the safest possible manner. Ensure that manufacturing and converting processes incorporate safe work practice and limit the risk of ergonomic injury. Quality Design new systems and processes to deliver Six Sigma process capability levels. Improve existing process capability levels through thoughtful analysis and investments in new equipment and upgrades to existing processes. Work closely with the Technical and Operations teams to validate new manufacturing equipment, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Leverage the company’s systems and standards for procedures, work instructions, document management, and employee training. Ensure quality problems are quickly identified, contained, eliminated, and prevented from recurring. Respond to customer complaints through the disciplined application of the company’s CA/PA procedure. Contain potential problems, investigate causes, implement solutions and prevent the problem from recurring. Ensure that approach and results are communicated to the customer. Process Coordinate the efficient and effective specification, procurement and installation of new equipment and upgrades with suppliers and sub-contractors. Provide manufacturing insight and project deliverables to new or modified product projects and ensure timely transition into manufacturing, with consideration to robust design, cost effectiveness and process validation. Drive Overall equipment effectiveness (OEE) to best-in-class levels through targeted improvement and process control efforts, including work standards, robust training, statistical process control, error-proofing, rapid changeover methods, and thoughtful scheduling. Identify, deploy and report critical process control and monitoring methodologies. Support, monitor and improve factory preventive maintenance procedures and results; seek and act on gaps or improvement opportunities. Identify, justify, execute and report structural cost reductions to improve quality and cost performance including automation opportunities, alternate process selections and qualification, and defect reduction. Ensure that customer specifications are efficiently and effectively translated into a functional work order and capable manufacturing process. Provide key engineering oversight to manufacturing change management activities through execution and reporting of accurate, thorough and insightful test plans, protocols and reports consistent with company SOPs. Oversee engineering documentation and specification preparation, submission and approval to ensure accuracy and completeness. Write/update work instructions, procedures, calibration instructions, and test procedures as required. Work cross functionally to provide the information needed to maintain accurate Engineering Masters and Quality Documentation. Lead and report progress of key projects using appropriate methodologies and sound engineering approach to ensure continuous and quantum improvement. Basic Qualifications

Education

B.S. in Mechanical, Electrical, Manufacturing Engineering or closely related field

Experience

Experience – Process Engineer - 1 – 4 years Sr. Process Engineer - 5+ years

Other Requirements

Strong technical and mechanical skills including pneumatics, electrical controls, PLC programming. Project Management experience Experience with electronic and information systems including network communications, vision systems, and other data collection systems. Skilled communicator with strong speaking/presenting and technical writing skills. 2D and 3D CAD experience desired (AutoCAD 2D and Solidworks 3D preferred). Knowledge and experience in cGMP; knowledge of QSRs, and ISO 13485 desirable. Skilled in data analysis including manufacturing statistical concepts. Solid Microsoft Office skills and experience in enterprise applications.

Education and/or Experience