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Staff Process Engineer

The Staff Process Engineer manages Engineers and Engineering Technicians within the Process Engineering department, and is responsible for corporate wide process improvements and new equipment validations.The Staff Process Engineer may also be responsible for leading process improvement projects or CAPAs.This role has direct reports in the Process engineering function and is responsible for the support, guidance workload and development of his/her direct reports. Responsibilities Manage Process Engineering personnel responsible for new product or process improvements projects and for investigations, risk and processing equipment related dispositions, for non-conformances and complaints, including but not limited to NCR's, CAPA's, and Complaints. Lead cross-functional process improvement and business support teams. Write protocols and reports demonstrating strong technical writing, where background of projects and procedures are clearly presented and conclusions are definitively and clearly stated. Lead CAPA and other process improvement projects; identify key improvement initiatives, carrying the initiatives through to completion. Perform data analysis that includes use of statistical tools, trending, ability to perform correlation analysis and other calculations as required. Perform risk assessments independently and as a team applying techniques including FMEA and ALAP. Organizes individual and organizational development aligned to the Process Engineering strategy Manages his/her resources to ensure the appropriate support and leadership is provided to the projects and activities allocated to the PE team. Aligns closely with Quality Engineering, Processing, R&D and Marketing as appropriate to ensure efficient, effective and compliant projects are completed in a timely manner. Coordinate with internal and external personnel for standards, data, testing or other activities, as needed. Provide leadership in group regarding critical requirements for processing. Perform other duties as assigned. Qualifications MINIMUM JOB REQUIREMENTS   Education: Bachelor of Science in engineering or scientific field.   Experiance: 7+ years of engineering experience in a regulated industry 1-2 years direct management experience   Specialized Knowledge, Skill, and Abilities: Basic statistics (ANOVA, t-test) Proficient in Microsoft Office, specifically Word and Excel Proficient in Microsoft Project Strong verbal and written communication skills   Work Enviorment: Office Environment 70%, Laboratory 20%, Clean-room- 10%   Physical Demands: Be able to lift 25 lbs infrequently Travel up to 20% of the time. Gowning into a clean room environment when needed   PREFERRED QUALIFICATIONS   Education: Bachelor's degree in mechanical, bio-medical or manufacturing Engineering Master's Degree in Engineering or Science   Experiance: 7-10 years of process engineering experience in a regulated industry 2+ years direct management experience 2018-3613
Salary Range: NA
Minimum Qualification
8 - 10 years

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