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Senior Product Development Engineer

2 months ago

Wilmington, Delaware, United States Spectra Medical Devices LLC. Full time
Job Title: Senior Product Engineer

We are seeking a highly skilled Senior Product Engineer to join our team at Spectra Medical Devices LLC. As a key member of our product development team, you will be responsible for leading the design and development of our medical devices, ensuring they meet the highest standards of quality and regulatory compliance.

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 regulatory filings, including FDA 510k and CE mark technical files.
  • Manage and facilitate customer interactions, ensuring clear communication and timely delivery of technical solutions.
  • Stay up-to-date with US and International medical device regulations and standards.
  • Develop and maintain engineering drawings in SolidWorks and other CAD formats.
  • Conduct feasibility testing, analyze results, and provide recommendations for product improvement.
  • Identify and implement opportunities for continuous improvement.
Requirements:
  • BS degree in Engineering, preferably in Mechanical, Manufacturing, or Biomedical Engineering.
  • Minimum 5 years of relevant experience, or advanced degree with a minimum of 4 years of relevant experience.
  • Excellent organizational, verbal, written communication, and problem-solving skills.
  • Ability to work in a fast-paced environment, multi-task, and meet tight deadlines.
  • Reliability, attention to accuracy, detail, and timeliness.
  • Proficient in MS Office Suite, Visio, Project, and Minitab, SolidWorks, and other CAD software.
Preferred Skills:
  • 8+ years of product design and development experience in a manufacturing or industrial environment, preferably in an FDA-regulated environment.
  • In-depth experience with ISO 13485, FDA QSR, and EU MDR concepts and guidelines.
  • Technical writing experience.
  • Experience working in a start-up environment.

Spectra Medical Devices LLC is an equal opportunity employer and welcomes applications from diverse candidates. We offer a dynamic work environment, competitive compensation, and opportunities for professional growth and development.