Senior Mechanical Engineer
3 days ago
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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