Katalyst Healthcares and Life Sciences
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.
- 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).
- uthoring 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.
- Equipment Development, Component Qualification, Tool Design, Process Qualification, Engineering Build.