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PDS Tech Inc Manufacturing Engineer III in Bedford, Ohio

PDS Tech, Inc. is seeking a Manufacturing Engineer in Oakwood Village, OH.

Position Summary:

  • Lead Manufacturing Engineer on capital projects - overall project management, budget, schedule management, construction management, start-up, conceptual phases, project close-out, scope development, cost estimation, system design, equipment sizing and selection, procurement, installation, check-out, and validation (IQ/OQ & PQ).

  • Maintain engineering interface with business unit team - develop and maintain close working relationships with Research & Development, Quality, Manufacturing, Manufacturing Leadership, and Financial Operations.

  • Offer production support and troubleshooting assistance to Engineers, Production Staff, and Maintenance.

  • Provide innovative technical solutions required to meet business objectives with emphasis on safety and productivity.

  • Provide support to capital planning process, new product development, and process automation.

  • Perform validation of equipment, automation systems, data collection systems, and processes for the manufacturing operations.

  • This position will coordinate the activities of Engineering, Manufacturing, Quality, and other Company groups required to complete assigned equipment projects in support of the operation of the manufacturing facility. (design, construction, start-up and commissioning)

  • Support/manage the activities of assigned junior and contract personnel and ensure the quality of completed work.

  • Provide technical assessment and validation review/approval for engineering and process changes.

  • Investigate and close Problem Reports (PRs) and Non-Conformance Reports (NCRs) in a timely and effective manner. Implement Corrective and Preventive Action (CAPA) as appropriate.

  • Utilize Lean Manufacturing Tools such as Root Cause Analysis, Gemba, Visual Management and Poka-Yoke to continually improve manufacturing operations

Responsibilities:

  • Manage and/or apply extensive technical selection and validation engineering expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, and alteration of processes, systems or equipment.

  • Independently provide and direct technical support for process and/or equipment upgrades, replacements, and modifications in manufacturing and manufacturing support environments.

  • Effectively work with cross functional team to support and improve manufacturing processes and practices to ensure needs of all stakeholders are met

  • Work collaboratively with safety, quality, production, design, and supply chain teams to identify and execute improvements that allow the organization to meet business level goals

  • Develop, communicate, and execute project plans that lead to significant process improvement

  • Troubleshoot systemic validation issues, develop, organize, analyze, and present interpretation of results regarding operational issues or validation projects, and apply advanced validation engineering principles to the design and implementation of new or modified system or processes.

Qualifications:

  • BS/BA degree in Electrical or Mechanical Engineering or related industry experience.

  • Requires electrical and automation programming aptitude, verbal and written communication, and interpersonal and problem solving skills.

  • A minimum of 7 years of experience in a technical manufacturing environment with increasing levels of responsibility for a wide range of projects, including design, validation, and operation of manufacturing processes.

  • Must be able to work independently as well as with teams, organize and manage projects by defining milestones, budgets and schedules; prepare regulatory summaries and present validation to regulatory authorities.

  • Must have a thorough knowledge of validation principles, manufacturing processes, quality systems, engineering design and start-up fundamentals, regulatory agency expectations and industry trends.

  • Effectively prioritize work to meet business goals

  • Collaborate and communicate effectively with all organizational levels and functions

  • Results oriented

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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