Senior Mechanical Engineer

3 days ago

Columbus, Ohio, United States MILLENNIUMSOFT Full time
Job Summary

The Mechanical Engineer will lead the mechanical engineering activities to develop and commercialize complex instrumentation in the medication safety space. This technical leadership position requires a strong understanding of mechanical design, manufacturing, and testing. The individual will work cross-functionally to understand end-user requirements and map them to design specifications, developing an efficient architecture and ensuring a detailed and well-tested design.

Key Responsibilities

* Define, clarify, and document requirements
* Perform (or ensure the team performs) 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
* Decompose 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
* Collaboration/coordination with other R&D functional teams to integrate the full system and realize the functionality and performance

Requirements

* Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or similar
* Fluent in CAD modeling using Solidworks
* 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
* Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR, ISO 13845, ISO 14971, and IEC 60601 and collateral standards

Competencies

* 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

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