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's� 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.
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 (i.e. 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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