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Senior Biomedical Engineer

4 weeks ago


Minneapolis, United States Redbock - an NES Fircroft company Full time

Sr. Biomedical Engineer (Through end of April 2025 // REMOTE, team based in Minneapolis, MN):

Would ideally like to have kick-off meeting in Fridley to start the project but a fully remote resource is available for consideration


Top 3 Skills:

  1. Previously authored Medical device robust documentation for audit
  • Includes various Post Market documentation, including Regulatory Impact Assessments, Investigation and VoE reports for CAPAs, regulation change reports/standards assessment, etc.
  1. Candidates should have previous experience with regulations for Medical Device Sterilization, Packaging, Labeling, etc.
  2. Teamwork / Collaboration
  3. Drive/Initiative to hit goals


Primary Responsibilities:

To hit monthly document approval goals:

  1. Initiate meetings/conversations/collaboration with Neuro Standards Team (5 with 1 in India) and SMEs [sterilization, packaging, labeling, radio regulatory, risk, released products (SW/EE)]
  2. Work with this team to create and gain approval of documents.


Target Years of Experience: 4 years of experience authoring/reviewing medical device robust post market documentation in compliance with audit requirements


Description:

Create standard/regulation documentation to show gaps, plans, and final completion evidence. Initiate and drive cross-functional meetings to align with SMEs (sterilization, packaging, labeling, radio regulatory, risk, released products [SW/EE]) and Project team. Outcome of alignment is ability to author and execute documentation approval to achieve project monthly goals.


Duties:

  • Designs, develops and provides safety testing, repair, and maintenance of biomedical equipment.
  • Ensures that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards.
  • Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes.
  • Participate in activities such as compound screening and compound optimization programs, and developing and running enzyme assays.


Required Knowledge and Experience:

  • Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.