Engineering Project Lead

Reports to: Director of Engineering

Department: R&D and Engineering

Job Description and Responsibilities

• Lead, Plan & Coordinate end-to-end cross-functional activities of products in sustain & NPI phase.
• Develop a detailed project plan that is both holistic and detailed and considers design control deliverables (all technical aspects) and other deliverables required for a clinical study or commercial/regulatory launch.
• Coordinate regular project status update meetings and reviews with a cross-functional project team. Provide completion of project activities and project deliverables according to the project plan.
• Responsible for product integration, reliability, qualification, environmental, and safety tests in external LAB and in-house. Support products DHF & DMR lifecycle processes.
• Cross-functional project execution leadership, including concept discussion, System design, Design & Technical meetings, V&V and qualification tests, clinical and pilot trials, and product field delivery.
• Provide services to Clinical\Service\QA\RA\Operation\BD departments on Service calls, CC, CAPA, Wavers, regulatory submissions, etc.
• Initiate and lead the design reviews at the required stages of the project process.
• Generate, review, and provide feedback on designs, as well as product and regulatory documentation.
• Execution of engineering investigations and LOG analysis as part of NCRs, CAPA, and Customer complaints.
• Lead and maintain the Risk management file, Risk assessment, and FMEA for system elements according to QMS.
• Responsible for assessing risks arising from complaints, ECOs, CAPAs, etc., in the risk management file.

Education and Experience

• Bachelor’s Degree within an appropriate Mechanical/Biomedical/System discipline with Project Management experience in a medical multidisciplinary technology company or equivalent.
• Experience of at least 3-7 years in medical devices with development of medical multidisciplinary capital equipment and disposable units.
• Strategic planner and thinker
• Excellent knowledge in R&D, engineering, program management, and planning processes, and experience with the medical device product lifecycle.
• Demonstrated experience in product releases throughout the entire NPI cycle. Proven execution skills at meeting project goals with desired quality, performance, schedule & budget
• Strong written and oral communication skills
• Demonstrated problem-solving ability and results orientation.
• Familiarity with ISO13485, FDA, NMPA, PMDA, and other regulatory standards
• Experience in MS-Office, MS-Project, MS Planner – Must
• Experience in Solid works, LabView, Imaging SW – Advantage