Design & Development : Create and test prototypes, disease models, and product designs aligned with regulatory standards.
Clinical Collaboration : Work with KOLs and advisors to translate clinical needs into product solutions.
Testing & Validation : Conduct in-vitro, in-vivo, and V&V testing; develop protocols and reports.
Documentation & Compliance : Ensure quality system documentation and adherence to FDA regulations.
Supplier Management : Source and maintain relationships with component suppliers.
IP Development : Contribute to patent filings and invention disclosures.
Cross-functional Teamwork : Represent R&D on core teams and support pilot manufacturing.
Technical Leadership : Guide technology development teams and manage resources.
Qualifications
Education : Bachelors (Masters / PhD preferred) in Mechanical or Biomedical Engineering.
Experience :
10+ years in medical device engineering.
3+ years leading cross-functional teams.
Expertise in balloon catheters, access / delivery systems, and disposable devices.
Skills :
Strong material and design knowledge.
Effective communicator and independent operator.
Adaptable to fast-paced environments.
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Principal Engineer • Minneapolis, MN, US
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