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Product Engineer
4 months ago
Position :
Product Engineer
Location : San Diego, CA
Duration : 12 Months contract
Total Hours/week : 40.00
1st Shift
Description:
The Product Engineer position is a technical/project leadership position, responsible for leading the mechanical engineering activities to develop and commercialize medical disposables. The individual would have responsibility for working cross-functionally to understand end-user requirements and mapping them to design specifications and ensuring a detailed and well-tested design.
This position's responsibilities includes defining, clarifying, and documenting requirements; performing the necessary parametric analysis and tradeoffs; defining form factor, design the architect layout and sub-assemblies, recognizing when interface impacts might occur, creating project schedules/timelines and taking early action to avoid problems.
Responsibilities:
The responsibilities can include, but are not limited to: decomposing system level requirements to mechanical product design definition, analysis and problem solving, architect layout and detailed sub-assemblies and components design, design qualification and test activities and collaboration/coordination/leading with other cross functional team members to integrate the product and realize the functionality and performance.
The Product Engineer will be expected to interpret requirements and rationalize the design choices with the multi-disciplinary team, leveraging quantitative approaches and knowledge of both mechanical design 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 and getting projects done as scheduled is critical to success.
Minimum Qualifications:
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or similar
Minimum of 5 years of post-educational professional experience
Familiar with CAD modeling using SolidWorks or equivalent
Desired Qualifications:
Graduate degree in Mechanical Engineering, Biomedical Engineering or similar
8-10 years of post-educational experience in Medical Device Design
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
Experience as mechanical lead in the development 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
Competencies:
Excellent written & verbal communication skills
Sound management skills driving projects and tactfully leading teams to achieve goals.
Minimal direction 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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