Mechanical Engineer-Medical Device

Job Description

TITLE: Mechanical Engineer-Medical Device
DEPARTMENT: R&D Engineering Hardware
REPORTS TO: Design Engineering Manager

Position Summary

Under minimal supervision, design, develop and test all aspects of mechanical components and equipment.  Apply knowledge of engineering principles to assist in the design of the next generation Point of Care medical instrument and high volume consumable.

Principal Responsibilities

Responsibilities may include but will not be limited to the following as assigned:

  • Daily brainstorming, concept development, prototype and test.
  • Lead the design & release of a single use consumable which will support patient sample preparation, mixing, reagent flow, optical reading, & integration to the Genalyte POC Device.
  • Develop products from concept through to manufacturing handoff while maintaining strict design documentation (DHF) and revision control.
  • Drive rapid prototyping activities and select methods to evaluate product embodiments and efficiently inform design iterations.
  • Prepare and execute Engineering Change Order packages, including drawings, documentation and supporting data.
  • Co-ordinate across departments to write concise Product Requirement Documents for mechanical subsystems.
  • Design and execute statistically based R&D experiments for product development.
  • Root cause analysis of failures and technical problem solving.
  • Work closely with vendors to develop parts, custom materials, fixtures and processes for high volume manufacturing.
  • Maintain compliance with all applicable regulations, company policies, quality systems & procedures.
  • Conduct design reviews and provide technical updates to program managers and functional area management.
  • Perform other duties as assigned by supervisor.

Essential Requirements

  • BS in Mechanical Engineering, MS preferred
  • 10 + years of experience in related field
  • Experience in design of instruments and consumables for the Medical Market
  • Experience working in an FDA regulated environment
  • Working knowledge of & strict demonstrated adherence to IEC 60601, ISO 13485, 21 CFR 820.30 standards
  • Proficient with SolidWorks and PDM Works
  • Working knowledge of GD & T and tolerance analysis
  • Experience with high volume manufacturing processes such as injection molding, die cutting, laser bonding processes, surface treatment, is desired.
  • Excellent oral and written communication skills
  • Proficiency in MS Office, particularly data analysis using Excel
To apply please e-mail Cover Letter and CV to
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