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Process Engineer

Process Engineer

Katalyst HealthCares & Life SciencesCincinnati, OH
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Responsibilities :

  • Lead equipment development projects.
  • Prepare equipment development project proposals.
  • Conduct equipment development concept verification.
  • Perform SOW & risk analysis and mitigation. Evaluate equipment suppliers.
  • Oversee equipment design, design review, and verification
  • Follow up on equipment manufacture and delivery.
  • Conduct equipment acceptance tests (FAT / SAT).
  • Create equipment operation manuals, specifications, and technical drawings.
  • Oversee equipment installation and debugging.
  • Perform equipment operational tuning and improvements.
  • Verify equipment functionality and reliability.
  • Develop equipment operation and maintenance work instructions.
  • Validate equipment (validation protocol, execution, and report).
  • Provide training on equipment operation to maintenance and production teams. Manage equipment changes and upgrades.
  • Handle other assignments as assigned by a superior.

Requirements :

  • Must have experience in the medical devices industry as well as a basic understanding of the regulatory requirements.
  • Must have experience in Engineering Documentation for medical devices (Product Design & Development Documents, Protocols, Test Reports, MEMOs and Rationales for Engineering Activities.
  • Hands on prototyping, debugging, knowledge of inventory management.
  • Experience on equipment / tool development and qualification.
  • Good knowledge in design program / project approach and governance.
  • Experience in Design verification and Validation.
  • Knowledge of statistical analysis and its applicability to derive engineering rationale.
  • Knowledge of change management plans.
  • Preferred experience with design, engineering and functioning of surgical devices.
  • Development & Conduct of Engineering / Test Studies.
  • Experience in Process Qualification (IQ / OQ / PQ) and Factory Acceptance Testing.
  • Knowledge of Design of Experiments or Process Characterization.
  • Experience in different manufacturing and assembly process, DFMA principles
  • Experience in custom fixture / gauge design / Fail proof principles.
  • Exposure to trouble shooting and root cause analysis.
  • Preferred experience in process improvement strategies to improve efficiency and throughput.
  • Exposure in automation involving pneumatics / hydraulics / PLC'sØ Exposure to Optical Vision based measurement systems.
  • Exposure to Software requirements Development for assembly equipment.
  • Knowledge of Ergonomics and Safety requirements in equipment design.
  • Project management activities, including planning, developing and tracking schedules, and communication.
  • Should be able to do characterization, debugging and should be conversant with Windchill (good to have).
  • Evaluate equipment suppliers.
  • Oversee equipment design, design review, and verification. Follow up on equipment manufacture and delivery.
  • Conduct equipment acceptance tests (FAT / SAT). Create equipment operation manuals, specifications, and technical drawings.
  • Collaborating with cross-functional teams to gain alignment on project plans and testing strategies.
  • Prepare equipment development project proposals.
  • Conduct equipment development concept verification.
  • Coordinating with other projects to determine the product configuration strategy (which version of each product will be tested).
  • Authoring and leading the activities ( component development, Engineering built and verification, validation etc.) through the Ethicon change control system.
  • Driving the activities of each line transfer, including tactical planning and logistics to navigate obstacles.
  • Coordinating with other team members executing the transfer.
  • Root cause analysis and troubleshooting for issues post transfer.
  • Critically reviewing test protocols and reports.
  • Travel to different Manufacturing plants.

    • Keywords :

  • Equipment Development, Component Qualification, Tool Design, Process Qualification, Engineering Build.
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    Engineer • Cincinnati, OH