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
An established and growing law firm that cares deeply, moves fast, and never loses sight of the human side of what we do.
Company Description
An established and growing law firm that cares deeply, moves fast, and never loses sight of the human side of what we do.
Numbers & Facts
Location
Santa Ana, CA
Skills
3D Modelingunmatched
Analysis Skillsunmatched
Biomedicineunmatched
Build Managementunmatched
Catheterizationunmatched
Dental Insuranceunmatched
Documentationunmatched
Engineeringunmatched
Engineering Drawingunmatched
Establish Prioritiesunmatched
FDA (Food and Drug Administration)unmatched
Federal Laws and Regulationsunmatched
IP (Internet Protocol)unmatched
ISO (International Organization for Standardization)unmatched
Legalunmatched
Life Insuranceunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Mechanical Engineeringunmatched
Medical Equipmentunmatched
Multitaskingunmatched
People Managementunmatched
Pre-Clinical Trialsunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Process Developmentunmatched
Product Supportunmatched
Prototypingunmatched
Quality System Requirements (QSR)unmatched
Regulatory Complianceunmatched
Research & Development (R&D)unmatched
Risk Analysisunmatched
Risk Managementunmatched
Safety/Work Safetyunmatched
SolidWorksunmatched
State Laws and Regulationsunmatched
Team Playerunmatched
Technical Analysisunmatched
Technical Presentationunmatched
Technical Writingunmatched
Test Plan/Scheduleunmatched
Testingunmatched
Time Managementunmatched
Validation Testingunmatched
Willing to Travelunmatched
Writing Skillsunmatched
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