Mechanical Design Engineer

Job DescriptionJob Description

Gentis Solutions is seeking a Mechanical Design Engineer for a direct hire full-time position with one of our clients. The ideal candidate will be able to apply their knowledge in product development and engineering sustaining activities. If you are qualified, make sure you apply.

Requirements

• Bachelor of Science degree in Mechanical Engineering
• Exposure to and/or basic engineering understanding of principles associated with electro-mechanical/hydraulic devices to include DC motor, pump, cylinder, valve body and control system design
• Exposure to and/or basic engineering understanding of basic design principles related to injection molding, metalworking, machining, castings, aluminum extrusions, welding, battery technologies, and electrical systems (PCB/Firmware/Software)
• Exposure to and/or basic engineering understanding of ISO and FDA-regulated design control requirements for medical devices
• With direction, ability to make decisions in regard to compliance, product reliability, and analysis of testing methodologies
• Working knowledge of SolidWorks CAD Software as it pertains to mechanical system layout
• Working knowledge of GD&T/ANSI standards
• Strong product affinity and results orientation

Typical Duties

• Engineering design team member of electro-mechanical pre-hospital patient handling products and sub-systems
• Design and re-design of FDA, ISO 13485, CE, ISO 14971, MDD 93/42/EEC, MDR compliant medical devices
• Participate in Engineering Change Order and/or Phase-Gate processes for assigned programs to include QMS compliance
• Participate in the formulation of design specifications, material specifications, concept, prototyping, tolerance stack-ups, DFM, DFA, DFS, vendor integration, design reviews, FMEA development, usability assessment, design transfer readiness and introduction
• Accountable for design history file and technical file documentation and other controlled documents under regulatory framework
• Review product verification and validation test plans and results. Provide feedback to development teams
• Work with test engineering, quality and regulatory to ensure products maintain certification to various standards
• Lead communication on assigned programs and provide issue escalation support to internal and external customers
• Maintain and update design drawings and models utilizing CAD; Solidworks experience is required
• Conduct design reviews for updated legacy or new product designs
• Assist in diagnosing field issues and developing corrective actions
• Ensure compliance with all regulatory and compliance activities within prescribed area
• Develop solutions to improve product quality and reduce product cost

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