Lead Manufacturing Engineer

DanaherDuncan, OK
3d

About The Position

The Lead Manufacturing Engineer is responsible for supporting global manufacturing initiatives consisting of process innovation projects, introduction of new products, supporting global multi-site process standardization, and digitization of manufacturing processes, and transfers of production into various Cytiva operations business units globally. What you will do: Engage with Strategic, Technical and Operational global manufacturing teams to enhance existing manufacturing process and implement new innovative solutions. Work in close collaboration with RD&E and other stakeholders to ensure that Manufacturing/Operations project requirements are well defined and implemented. Drive rigor on supply chain aspects including Product Life Cycle Management. Manage Risks & Mitigation Planning through creative solutions. Represent manufacturing on a global cross-functional business project teams and Process development teams. Ensure regulatory compliance through Validation & Verification. Responsible for determining processes requiring validation, development of plans and analysis criteria, execution of final analysis and acceptance. Work closely with your local engineering peers as well as global manufacturing engineers to drive improved product quality and productivity by identifying manufacturing issues, developing cost effective solutions, and successfully implementation of improved solutions into production. Comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, regulatory and applicable laws and regulations. Identify and report any quality or compliance concerns and take immediate corrective action as required.

Requirements

  • Minimum 3 years of progressive responsible post-Bachelor s degree experience in related occupation required.
  • Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering or related technical field
  • Minimum 3 years of experience in production or engineering, regulated / medical device or related industry experience.
  • Minimum 3 years of experience with Project Planning and Project Management and managing multiple projects to successful completion.
  • Minimum 3 years of experience of Innovation, Development, Testing and Qualification.
  • Ability to travel – 15% travel globally
  • Must have a valid driver’s license with an acceptable driving record
  • Ability to lift, move or carry equipment up to 35lb, any other physical requirements

Nice To Haves

  • Equipment automation theory and design.
  • Manufacturing of single use technologies for consumables and hardware products (Mixers and Bioreactor).
  • Lean manufacturing, design for manufacturing, 5S, 3P, root cause analysis, six sigma and statistical tools & analysis.

Responsibilities

  • Engage with Strategic, Technical and Operational global manufacturing teams to enhance existing manufacturing process and implement new innovative solutions.
  • Work in close collaboration with RD&E and other stakeholders to ensure that Manufacturing/Operations project requirements are well defined and implemented.
  • Drive rigor on supply chain aspects including Product Life Cycle Management.
  • Manage Risks & Mitigation Planning through creative solutions.
  • Represent manufacturing on a global cross-functional business project teams and Process development teams.
  • Ensure regulatory compliance through Validation & Verification.
  • Responsible for determining processes requiring validation, development of plans and analysis criteria, execution of final analysis and acceptance.
  • Work closely with your local engineering peers as well as global manufacturing engineers to drive improved product quality and productivity by identifying manufacturing issues, developing cost effective solutions, and successfully implementation of improved solutions into production.
  • Comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, regulatory and applicable laws and regulations.
  • Identify and report any quality or compliance concerns and take immediate corrective action as required.
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