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Mechanical Engineer

Mechanical Engineer

ConfidentialWestfield, IN, US
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Job Title : Mechanical Engineer

Location : Westfield, IN

Requirements :

  • Collaborates with manufacturing to develop, document, implement, and train staff on high capability manufacturing and test processes.
  • Conducts product testing as needed.
  • Creates CAD models and prototypes.
  • Designs, sources, builds, and debugs fixtures and tooling for manufacturing and product development.
  • Analyzes and optimizes manufacturing processes.
  • Evaluates and designs components and subassemblies for manufacturability.
  • Applies valid industrial research and applied statistics for process control.
  • Prepares engineering protocols, executes plan, gathers data, analyzes the results, and writes clear and concise reports.
  • Implements basic project management goals, schedules, tracking, and reporting.
  • Works within medical device regulations and conforms with the Quality Management System.
  • Collaborates with assemblers and technicians to write clear assembly and test procedures and resolve technical issues.
  • Participates in structured failure and root cause analysis for issue resolution
  • Develops and executes qualification studies, including verifications and validations.
  • Works mostly autonomously but requires direction to accomplish complex projects and tasks.
  • Works well in a team setting and interdepartmentally with colleagues.

Qualifications :

  • Requires a bachelor's degree of Mechanical Engineering, Industrial Engineering or Manufacturing Engineering or related experience.
  • Typically requires 5-7 years of related experience.
  • A background in Lean Manufacturing tools and techniques is a plus.
  • Must have good SolidWorks modeling and drafting skills per ASME Y14.5.
  • Must be proficient with MS 365 tools.
  • Must have good oral and written communication skills.
  • Must have experience working within medical device regulations (ISO 13485, ISO 14971, FDA 21 CFR 820) and work must conform with the Quality Management System
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    Mechanical Engineer • Westfield, IN, US