Job Description
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
- Education: 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.