R & D Engineer

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

Established and growing aerospace manufacturing company whose products are found in nearly every aircraft.