Sr. Mechanical Engineer Job at MillenniumSoft Inc (Franklin Lakes)

Job Description

The Mechanical Engineer position is a technical leadership position, responsible for leading the mechanical engineering activities to develop and commercialize complex instrumentation in the medication safety space. The individual would have responsibility for working cross-functionally to understand end-user requirements and mapping them to design specifications and developing an efficient architecture, ensuring a detailed and well-tested design. This position's responsibilities includes defining, clarifying, and documenting requirements; performing (or ensuring the team performs) the necessary parametric analysis and tradeoffs; define form factor, design the architect layout and sub-assemblies, recognizing when interface impacts might occur and taking early action to avoid problems.

Job Responsibility

decomposing system level requirements to mechanical design definition, analysis and problem solving, architect layout and detailed sub-assemblies and components design, design qualification and test activities and collaboration/coordination with other R&D functional teams to integrate the full system and realize the functionality and performance.
interpret requirements and rationalize the design choices with the multi-disciplinary team, leveraging quantitative approaches and knowledge of both mechanical design and manufacturing considerations, design, assemble and evaluate rapid prototype models in order to assess technical feasibility of various solutions.
work in a “hands on” manner to develop engineering prototypes, work with external suppliers, qualify and select optimal parts

Requirements

Graduate degree in Mechanical Engineering, Biomedical Engineering or similar
8+ years of post-educational experience in Medical Device Design
5+ years of SolidWorks experience with CAD and drawing
Electromechanical Design experience (sheet-metal, plastic, working with PCB in an assembly)
Test Fixture Design experience
Experience with design best practices, including advanced tolerance design/analysis
Experience talking to supplier and gathering relevant information
Experience in defining a performance test is preferred
Experience as mechanical lead in the development of complex electro-mechanical devices
Proficiency with basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies.
Expertise in common risk management techniques (FMEA, FTA, ETA).
Experience in modeling, simulations and sensitivity analyses.
Experience in the development of complex instrument systems involving hardware, electronics, and optics, ideally in a healthcare, medical technology
Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR, ISO 13845, ISO 14971 and IEC 60601 and collateral standards
Excellent written & verbal communication skills
Self-directed with the ability to learn and adapt quickly to new technologies and trends
Strong organization and coordination skills
Demonstrated customer focus, track record of innovation and publication
Must be comfortable making practical assumptions with engineering justifications, where needed.
Ability to work independently.
Ability to work under pressure and time constraints.
Effective interpersonal and collaborative skills.
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or similar
Fluent in CAD modeling using SolidWorks

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Sr. Mechanical Engineer

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