Design Assurance Engineer

5 days ago


Saint Paul, United States Intellectt Inc Full time

Role: Design Assurance Engineer

Location: St. Paul, MN - 55117

Duration: 6 Months on W2


Skills Looking For:

- Design Assurance Engineer position.

- Domain: Design and development- medical electrical equipment.

- Computer science background, med device software development background (not writing code, heavily involved in verification and validation of medical devices, medical electrical equipment and medical software in particular.

- This assignment will be a support project for software release with compatibility with other hardware elements.

- Regulation 62304 software development med device experience.

- Day to Day: Understand software requirement specification, know how it translates into verification plans, write verification plans - software configurations, software acceptance criteria, write test plans and write reports and put them into doc control system. They will not conduct the tests (it will be performed by a team of technicians).

- Heavy on software verification testing.

- If the candidate understands Non-product software verification it is a plus (not med device software, it is equipment and tools. R&D tools like emulators, and simulators).

- 14971 med device risk management experience will be helpful.

- Med device exp is required.

- Not looking for a Software coder.


Education and Experience:

- Bachelor's degree required (Computer science preferred open to Electrical or Biomedical as well)

- Minimum of 3 years of experience is required.

- More experience the better, as long as they are available at the given bill rate.


Top 3 Skills:

- Software development lifecycle

- Verification and validation methodologies

- Equipment qualification



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