Lead Development Engineer

4 weeks ago


Philadelphia, Pennsylvania, United States Proclinical Staffing Full time

Lead Development Engineer - Orthopedic Medical Devices

Proclinical Staffing is seeking a highly skilled Lead Development Engineer to lead the development of orthopedic minimal invasive therapy devices.

Key Responsibilities:

This role involves leading the full life cycle development of orthopedic medical devices, from conceptualization to commercial market launch. The successful candidate will work closely with the Chief Medical Officer to assess clinical needs and manage product development programs.

Requirements:

  • BS in engineering (mechanical or biomedical preferred)
  • 3-5 years experience in project leadership alongside 8-10 years of hands-on product development experience, ideally in medical device product development
  • Experience transitioning a product into manufacturing and distribution
  • Knowledge of Quality Systems, Quality Assurance best practices, and Regulatory Compliance
  • Experience ensuring FDA, GMP, and ISO compliance involving Design Control and maintenance of Design History Files (DHF)
  • Experience with orthopedic implant medical devices is desired

The Lead Development Engineer's responsibilities will be:

  • Lead the full life cycle development of orthopedic minimal invasive therapy devices
  • Collaborate with the Chief Medical Officer to assess clinical needs and develop design inputs and outputs
  • Manage product development programs and maintain master project schedules
  • Oversee internal and external engineering and manufacturing resources
  • Contribute to hands-on design, design reviews, and technical documentation
  • Support the creation of solid models/drawings and manufacturing prototypes
  • Support pre-clinical laboratory testing and animal studies, including protocol development and generating final reports
  • Lead Risk Management activities throughout the product life cycle
  • Analyze and evaluate product defects, perform failure investigations, and implement corrective and preventive actions


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