Product Development Engineer

3 days ago


Reston, Virginia, United States INFRAREDX Full time

Job Summary:

We are seeking a highly skilled Product Development Engineer to join our team at INFRAREDX. As a key member of our R&D team, you will be responsible for the development of electromechanical systems for the diagnosis and treatment of cardiovascular disease.

Responsibilities:

  • Design and develop electromechanical systems for medical devices, ensuring compliance with regulatory requirements.
  • Collaborate with cross-functional teams to develop and implement product design and development strategies.
  • Conduct research and development activities to improve product performance and efficiency.
  • Develop and maintain technical documentation, including design specifications, test plans, and validation reports.
  • Provide design support to manufacturing and sustaining teams, recommending and implementing modifications and corrective actions as needed.
  • Participate in the development of new products and technologies, utilizing a cross-functional team of engineers and scientists on complex projects.
  • Perform verification testing and assemble prototypes, developing initial manufacturing instructions.
  • Partner with manufacturing to investigate and solve critical production process problems.
  • Perform product and process risk analysis and statistical analysis of test data.
  • Complete returned product complaint investigations as needed.

Qualifications:

  • Bachelor's degree in a related engineering field.
  • 0-2 years of experience in medical device development.
  • Proficiency in 3D CAD and drafting software (SolidWorks).
  • Experience with design for manufacturing and process development is preferred.
  • Experience with component design of machined parts, sheet metal parts, and molded parts is preferred.
  • Experience with mechanical design of electromechanical or controls systems is preferred.
  • Ability to independently organize and align project tasks with department priorities.


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