The Staff Mechanical Engineer position is a technical leadership position, responsible for leading mechanical engineering activities to develop and commercialize disposable infusion sets and related components. This individual will 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 design analysis and tradeoffs; designing the disposable layout and defining sub-components, recognizing when interface impacts might occur and taking early action to avoid problems. Interfacing with Companys SAP and CAD PLM systems to manage projects in our design control environment.
The responsibilities can include, but are not limited to: decomposing system level requirements to disposable design definition, conducting robust design and analysis, problem solving/ failure analysis, disposable layout and component design, design verification and validation test activities and collaboration/coordination with other cross functional teams (quality, manufacturing, regulatory, marketing, etc.) to realize the systems functionality and performance and eventual product release.
The Staff Engineer will be expected to interpret requirements and rationalize the design choices with the multi-disciplinary team, leverage quantitative approaches and knowledge of both mechanical design and manufacturing considerations, design, assemble and evaluate prototype models in order to assess technical feasibility of various solutions. Ability to work in a hands on manner to develop engineering prototypes, work cross functionally with internal / external customers and external suppliers, qualify and make design and engineering decisions critical to success.
Bachelors degree in Mechanical Engineering, Biomedical Engineering or similar
Minimum of 5 years of post-educational professional experience
Experience using PLM and CRM systems
Extensive experience solving problems and well versed in critical thinking
Systems and requirements engineering experience
Strong leadership and team building skills
Graduate degree (MS or Phd) in Mechanical Engineering, Biomedical Engineering or similar
5+ years of post-educational experience in Medical Device Design
Experience with design best practices, including advanced tolerance design, and design for reliability.
Design for Six Sigma, Design for Manufacturability training / experience
Experience with injection molded plastics and design of high-volume disposables.
Experience as mechanical lead in the development of medical disposable 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 development using cross-functional teams ideally in a healthcare, medical technology or life sciences area.
Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral standards
Excellent written & verbal communication skills
Ability to challenge the status quo in light of development efficiency while maintaining a robust design and design standards.
Self-directed with the ability to learn and adapt quickly to multiple and competing requests.
Strong organizational, influencing and coordination skills.
Demonstrated customer focus, and track record of releasing products.
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.