This is a great opportunity for a hands-on engineer who wants to design and develop next-generation medical devices, with strong potential exposure to the endovascular catheter space.
What You'll Do
- Design and develop medical devices and related accessories
- Develop and execute engineering tests, including benchtop, verification & validation (V&V), and pre-clinical studies
- Create comprehensive test protocols and reports
- Design and build tools, jigs, and fixtures to support prototyping, manufacturing, and testing
- Create sketches and detailed design concepts; perform measurements, analyses, and build engineering prototypes
- Communicate project status, risks, and opportunities to the project team and management
- Contribute to the company's IP base through active idea generation and concept development
- Assemble product drawings, specifications, risk analyses, and technical documentation; maintain proper documentation within the Design Dossier and Design History File (DHF) for regulatory compliance
- Support product transfer and scale-up activities
- Ensure compliance with quality system procedures and applicable federal, state, and local regulations, as well as company Health, Safety, and Environmental policies
- Help maintain the R&D lab to support efficient prototyping and process development
- Manage direct or indirect reports as needed
What You Bring
- Bachelor's degree or higher in Biomedical, Materials, or Mechanical Engineering
- Minimum 2 years of engineering experience in development or manufacturing within a regulated medical device environment
- Experience in the endovascular catheter industry is a strong plus
- Working proficiency in SolidWorks for 3D modeling and engineering drawings
- Strong analytical, critical thinking, and problem-solving skills
- A collaborative, team-first mindset
- Sense of urgency with the ability to multitask, prioritize, manage risk, and meet deadlines
- Excellent written and verbal communication, presentation, and technical writing skills
- Familiarity with FDA submission processes, ISO requirements, and QSR requirements preferred
- Ability to travel approximately 5% of the time, domestically and internationally
- Ability to travel to Temecula as needed for development and product transfer projects
Health and Wellness
- Comprehensive medical, dental, and life insurance plans
- Flexible Spending Accounts (FSA)
- Gym memberships or wellness perks []
Financial and Retirement
- 401(k) retirement plan with company matching
- Performance-based bonuses (up to 20% for certain engineering tiers) []
Time Off and Professional Growth
- Generous paid time off, including vacation and sick leave
- Paid company holidays (averaging around 11 days per year)
- Academic and tuition reimbursement programs
