Job Description Summary
The Staff Mechanical Engineer position is a technical leadership position, responsible for leading the mechanical engineering activities to develop and commercialize complex electro-mechanical 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.
The responsibilities can include, but are not limited to: 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.
The Staff Engineer will be expected to interpret requirements and rationalize thedesign choices with the multi-disciplinary team, leveragingquantitative approaches and knowledge of bothmechanicaldesign and manufacturing considerations,design, assemble and evaluate rapid prototype models in order to assess technical feasibility of various solutions. Ability to work in a “hands on” manner to develop engineering prototypes, work with external suppliers, qualify and select optimal parts is critical to success.
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or similar
- Minimum of 8years of post-educational professional experience, with focus on mechanicaldesign with at least 2 years of project leadership experience
- Fluent in CAD modeling using Solidworks or ProE
- Graduate degree in Mechanical Engineering, Biomedical Engineering or similar
- 10+ years of post-educational experience in Medical Device Design, preferably complex electro-mechanical devices
- Experience as mechanical lead in the development of complex electro-mechanical devices
- Experience in development of cross-functional systems, including integration with analog/digital signal processing, electrical/electronic systems, motion control systems, and optical systems.
- Experience in the development of complex instrument systems involving hardware, electronics, and optics, ideally in a healthcare, medical technology or life sciences area.
- Experience with design best practices, including advanced tolerance design, design for reliability, and design for reusability.
- Design for Six Sigma, Design for Manufacturability training / experience
- Experience with injection molded plastics and design of high-volume disposables
- 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
- 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.
Job ID R-309272