Sr. Process Engineer

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.

• 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.

• 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.

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

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

• Strong technical and mechanical skills including pneumatics, electrical controls, PLC programming.
• 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 :

• 3-5 years minimum experience in closely related function

• Prolonged periods of sitting at a desk and working on a computer.
• Manufacturing environment .
• Must be able to lift up to 50 lbs.
• Various levels of gowning are required .

• Ability to travel (US and internationally)
• Ability to work evenings and/or weekends