Demo

Product Engineer

Current Opportunities
Sheboygan, WI Full Time
POSTED ON 3/26/2025
AVAILABLE BEFORE 5/26/2025

Duties & Responsibilities:

  • Manage product development projects within a defined Product Development System, beginning with Voice of the Customer concepts through successful steady-state production implementation; directly provide necessary engineering contributions for project success
  • Coordinate and manage new product introduction schedules and cross-functional activities throughout the development process.   Manage cross-product issues throughout the product life cycle. Lead quality improvement efforts as required
  • Create and manage BOMs and routings for new products
  • Conduct all appropriate risk management activities related to the design and development of medical devices in compliance with FDA/CE/Health Canada/etc. requirements
  • Create and manage engineering documentation (including 3-D models, 2-D drawings, Engineering Specifications, and manufacturing procedures) necessary for the proper manufacturing of products
  • Define and develop test protocols to evaluate product features and functionality
  • Define and develop manufacturing processes related to new products; work with process engineers to integrate new products into existing processes
  • Provide technical support and assist in the resolution of manufacturing problems as required
  • Provide technical resolution of customer complaints relative to assigned product lines
  • Communicate the status of projects to all levels within the organization
  • Pursue and support cost reduction activities to achieve established company goals
  • Review, process, and approve Engineering change orders applicable to product line responsibilities
  • Maintain a general awareness of and explore promising new materials and methods applicable to orthodontic products
  • Develop a deep understanding of manufacturing process capabilities, giving them full consideration during design and development activities
  • Perform additional responsibilities as requested to achieve business objectives

Qualifications:

  • BS in Mechanical or Biomedical Engineering or equivalent required
  • 3 - 5 years’ experience in product engineering Experience with managing product development projects desired
  • Experience with SolidWorks or equivalent CAD software and MS Office
  • Strong ability to communicate both verbally and in writing is required
  • Experience managing projects desired
  • Understanding of FEA techniques, DFM, FMEA, DOE, SPC, QFD, and industrial statistics
  • Demonstrated data-driven problem-solving ability required
  • Basic understanding of regulatory requirements for medical device design control and manufacturing strongly desired
  • Knowledge of Lean Concepts and Six Sigma desired
  • Experience with manufacturing process control desired

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