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Associate Design and Test Engineer
2 months ago
MiRus LLC is a leading medical device company that specializes in the design and manufacturing of innovative cardiovascular, orthopedic, and spinal systems. We are seeking an experienced Electrical Design and Test Specialist to join our development team.
Key Responsibilities- Support the development of medical electronics design, ensuring compliance with FDA regulations and industry standards.
- Prototype and test early designs for feasibility studies, utilizing ECAD tools such as Altium, KiCad, or Cadence.
- Write and execute test protocols and reports for electrical testing, analyzing design for failure mechanisms using FMEA.
- Collaborate with manufacturing to produce PCBs, designing test fixtures for automated testing of medical designs.
- Develop and maintain quality controls consistent with FDA regulated design, ensuring adherence to ISO 13485 standards.
- Bachelor's degree in Electrical Engineering, Engineering, or a related field.
- Strong experience with embedded C and C++ programming languages, as well as automation script coding (Python, LabVIEW).
- Proficiency in MCAD tools such as SolidWorks or equivalent.
- Experience in working in a regulated medical environment under ISO 13485, with knowledge of medical electrical safety standards.
- Experience with Linux architectures is a plus.
- Experience in medical device design and development, with a strong understanding of FDA regulations and industry standards.
- Knowledge of medical electrical safety standards and experience with testing and validation.
- Experience with Agile development methodologies and version control systems.
