JD: Degree in Mechanical, Materials or Biomedical Engineering with minimum 4 years of experience. · Perform Gap Assessment - Equipment on the floor, Gap Assessment / review on existing change control Process & Documents. · Create / update the manufacturing procedures. · Develops and executes Engineering studies and Process validation protocols and Summary reports (Installation Qualification, Operation Qualification, Process Qualification and Test Method Validation) · Vendor Coordination to source equipment. · Perform TMV / Protocol / Execution / Report · Perform FAT. · SOP (Standard Operating Procedure) create / update as needed. · Fixture design, development and verification. · Process improvements as needed · Working independently with the internal and external stakeholders for execution. · Prepare reports, presentations, and spreadsheets of an analytical and interpretative nature. · Collaborate with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements. · Maintain accountability to the completion of specific programs and projects in accordance to agreed project deliverables. · Use advanced techniques to anticipate, identify and develop solutions or alternatives to a variety of common and uncommon problems having a range of complexity. · Provide leadership, training, and mentorship to less experienced team members. · Demonstrated ability to manage and prioritize multiple tasks/projects with a strong problem-solving ability. · Adhere to safety policy procedures.
