Senior Product Development Engineer

1 day ago


Wilmington, Delaware, United States Spectra Medical Devices LLC. Full time
Product Development Engineer

Spectra Medical Devices LLC. is seeking a highly skilled Product Development Engineer to join our team. As a key member of our product development team, you will be responsible for leading the design and development of our medical devices.

Key Responsibilities:

  • Lead projects from conceptualization to design transfer, ensuring timely and within-budget delivery.
  • Develop and maintain design files, technical documentation, and project management plans.
  • Collaborate with cross-functional teams to integrate materials, methods, and tools for new product development.
  • Support the development of regulatory files, including FDA 510k and CE mark technical files.
  • Stay up-to-date with US and International medical device regulations and standards.

Requirements:

  • BS degree in Engineering (Mechanical, Manufacturing, or Biomedical preferred).
  • Minimum 5 years of relevant experience or advanced degree with 4 years of experience.

Preferred Skills:

  • 8 years of product design and development experience in a manufacturing or industrial environment.
  • Experience with ISO 13485, FDA QSR, and EU MDR concepts and guidelines.
  • Excellent organizational, verbal, written communication, and problem-solving skills.

Physical Demands & ADA Statement:

The physical demands described within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



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