Engineering Project Lead

Job Description and Responsibilities

• Lead, plan, and coordinate end-to-end cross-functional activities of products in sustain and NPI phases.
• Develop a detailed project plan that is both holistic and detailed, considering design control deliverables (all technical aspects) and other deliverables required for a clinical study or commercial/regulatory launch.
• Schedule regular project status update meetings and reviews with a cross-functional project team. Ensure the completion of project activities and deliverables according to the project plan.
• Responsible for product integration, reliability, qualification, environmental, and safety tests in external labs and in-house. Support products DHF & DMR lifecycle processes.
• Provide cross-functional project execution leadership, including concept discussion, system design, design & technical meetings, V&V and qualification tests, program execution, clinical and pilot trials, and product field delivery.
• Provide services to Service, Clinical, QA, RA, Operation, and BD departments on service calls, CC, CAPA, waivers, regulatory submissions, etc.
• Initiate and lead design reviews at required stages of the project process.
• Manage local and overseas subcontractors with availability to travel abroad and domestically.

Education and Experience:

•  Bachelor’s degree in mechanical engineering with project management experience in a medical multidisciplinary technology company or equivalent.
• 2-5 years of experience in medical device development, including medical multidisciplinary capital equipment and disposable units.
•  Strategic planner and thinker.
• Excellent knowledge of R&D, engineering, program management, and planning processes, as well as experience in the medical device product lifecycle.
• Demonstrated experience in product releases throughout the entire NPI cycle. Proven execution skills in meeting project goals with desired quality, performance, schedule, and budget.
• Strong written and oral communication skills.
• Demonstrated problem-solving ability and results orientation.
• Familiarity with ISO13485, FDA, NMPA, PMDA, and other regulatory standards.
• Proficiency in MS Office, MS Project, and MS Planner is a must.
• Experience in SolidWorks, LabView, and Imaging software is an advantage.

Pls send CV to mails: andreys@icecure-medical.com & meravnd@icecure-medical.com