Key Responsibilities
Create and test prototypes, disease models, and product designs aligned with regulatory standards.
Work with KOLs and advisors to translate clinical needs into product solutions.
Conduct in-vitro, in-vivo, and V&V testing; develop protocols and reports.
Ensure quality system documentation and adherence to FDA regulations.
Source and maintain relationships with component suppliers.
Contribute to patent filings and invention disclosures.
Represent R&D on core teams and support pilot manufacturing.
Guide technology development teams and manage resources.
Qualifications
Bachelor's (Master's / PhD preferred) in Mechanical or Biomedical Engineering.
Principal Engineer • Minneapolis, MN, US