דרושים בתחום הנדסת מכונות

A lead medical company is looking for a Mechanical Engineer
Design and implement mechanical engineering solutions for projects related to aesthetic laser systems and accessories.
• Creates and modifies work instructions and test procedures for manufacturing processes.
• Review, approve and create validation protocols (IQ, OQ, PQ) for subcontractors and/or vendors.
• Work together with cross functional team (production, quality, supply chain, regulatory, etc) to complete product transfers, design transfers and vendor transitions.
• Review and approve engineering change requests. Utilize change control process to make required changes to Device Master Record(s).
• Train production floor workers at sub-contractors and vendors on approved changes to the Device Master Record
• Design and create mechanical test fixtures and jigs to support production.
• Ensure compliance with Quality standards, mechanical standards, and regulatory requirements.
• Prepare for and participate in comprehensive design reviews and ensure that mechanical engineering standards are met, designs are technically viable, risks appropriately identified, and mitigation plans are put in place.

•Bachelor’s degree in mechanical engineering, master’s degree advantage
•Minimum of 3 years of related experience as mechanical engineering
•Proficiency in SolidWorks required, CAD
•Experience working with complex medical devices in an ISO 13485 certified QMS (Quality management system), strongly preferred.
•Experience in Operations /Supply Chain/ Logistics – not R&D