Staff Engineer - San Diego

The Staff 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 BD’s SAP and CAD PLM systems to manage projects
in our design control environment.

Responsibilities:
o   Developing project plans and executing and/or delegating work appropriately
o   Identification of project tasks/ needs and assigning resources as needed
o   Decomposing system level requirements to disposable design definition, conducting robust design
and analysis
o   Problem solving/ failure analysis, disposable layout and component design, design verification
and validation test activities andcollaboration/coordination with other cross functional teams
(quality, manufacturing, regulatory, marketing, etc.) to realize the systems functionality and
performance and eventual product release
o   Interpret requirements and rationalize the design choices with the multi-disciplinary team
o   Leverage quantitative approaches and knowledge of both mechanical design and manufacturing
considerations, design
o   Assemble and evaluate prototype models in order to assess technical feasibility of various
solutions
o   Ability to work in a “hands on” manner to develop engineering prototypes
o   Work cross functionally with internal / external customers and external suppliers
o   Qualify and make design and engineering decisions critical to success

Minimum Required Qualifications:

o   Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or similar
o   Minimum of 7-10 years of post-educational professional experience unless supplemented with a
Masters (5 years) or PhD (3 years)
o   Experience using PLM and CRM systems
o   Extensive experience solving problems and well versed in critical thinking
o   Systems and requirements engineering experience
o   Strong leadership and team building skills
o   Ability and willingness to travel between 10 to 20%.
 Desired Qualifications: 
o   Graduate degree in Mechanical Engineering, Biomedical Engineering or similar
o   10+ years of post-educational experience in Medical Device Design
o   Experience with design best practices, including advanced tolerance design, and design for
reliability.
o   Design for Six Sigma, Design for Manufacturability training / experience
o   Experience with injection molded plastics and design of high-volume disposables.
o   Experience as mechanical lead in the development of medical disposable devices
o   Proficiency with basic statistical techniques including familiarity with analysis of variance
(ANOVA) and design of experiment (DOE) methodologies.
o   Expertise in common risk management techniques (FMEA, FTA, ETA).
o   Experience in modeling, simulations and sensitivity analyses.
o   Experience in development using cross-functional teams ideally in a healthcare, medical
technology or life sciences area.
o   Experience creating and driving project plans, delegating tasks to resources as needed, and
ensuring successful completion thereof.
o   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

Competencies:
o   Excellent written & verbal communication skills
o   Ability to challenge the status quo in light of development efficiency while maintaining a robust
design and design standards.
o   Self-directed with the ability to learn and adapt quickly to multiple and competing requests. 
o   Strong organizational, influencing and coordination skills.
o   Demonstrated customer focus, and track record of releasing products.
o   Must be comfortable making practical assumptions with engineering justifications, where needed.
o   Ability to work independently.
o   Ability to work under pressure and time constraints.
o   Effective interpersonal and collaborative skills.