Principal R&D Engineer
SciProMinneapolis, MN, United Statesjob_description.job_card.variable_hours_ago
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionEducation : Bachelor’s (Master’s / 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.
Key Responsibilities
- 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
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Principal Engineer • Minneapolis, MN, United States