R & D Engineer

Job Description

Job Description

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

\nCompany Description

We are an AI native EMR platform built for operators of skilled nursing and assisted living facilities.

Company Description

We are an AI native EMR platform built for operators of skilled nursing and assisted living facilities.