• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Sr. Product Development Engineer

Job Number: 34035

Location:

Job Description

Under minimal supervision, primarily responsible for the design and development of new spinal products/product families and/or the enhancement of existing products. Involved in creating designs, modeling and drafting, utilizing a 3D CAD system. Other responsibilities include assisting in the development process with Marketing, Purchasing, Manufacturing, Quality, and Regulatory to help manage the project deliverables from conceptualization through full market launch.

Responsibilities

  • Research, develop, and design spinal implants & instruments in accordance with FDA and ISO requirements—New Product Development as well as maintenance of existing legacy systems.
  • Lead identification and timely execution of complete product development process and project deliverables, including concept design, testing, design finalization, verification/validation activities, transfer, and launch support.
  • Execute development activities of multiple line extensions and special instrument modifications in an abbreviated schedule simultaneously.
  • Create designs using CAD (SolidWorks) intended for both subtractive and additive manufacturing methods. Generate 3D part files, 3D assembly files, & 2D technical drawings.
  • Write protocols, execute, analyze test data, and generate reports to verify or validate that designs meet functional and performance specifications, including interactions with outside testing facilities.
  • Generates and manages the Change Order process for initial release & revision of device-related changes, including potential impacts on current design inputs, risk, and relevant controlled documents in the system Design History File.
  • Generates and manages the Change Order process for initial and updated revisions of appropriate Quality Management System documents and processes.

Required Skills

• Experience and Proficiency with CAD software required (SolidWorks preferred).
• Full working knowledge & experience with product development cycle and phased/gate approach of small to
medium projects.
• Knowledge of general manufacturing processes, and familiarity with common materials and practices to
produce medical implants and instruments. Experience with Additive Manufacturing preferred.
• Experience with GD&T, stack-up analysis, and mechanical testing.
• Experience and knowledge relevant ASTM, ISO, FDA standards, regulations, guidelines.

 

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