Mechanical Engineer

1 week ago

Franklin Lakes, United States MILLENNIUMSOFT Full time

Position : Mechanical Engineer

Location : Franklin Lakes, NJ

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Job Category: Engineering

Level Of Experience: Senior Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Job Description:

  • The Mechanical Engineer position is a technical leadership position, responsible for leading the mechanical engineering activities to develop and commercialize complex 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 Mechanical 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 is critical to success.

Minimum Qualifications:

  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or similar
  • Fluent in CAD modeling using Solidworks
  • Desired Qualifications:
  • Graduate degree in Mechanical Engineering, Biomedical Engineering or similar
  • 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.
  • Experience in the development of complex instrument systems involving hardware, electronics, and optics, ideally in a healthcare, medical technology or life sciences area.
  • 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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