R&D Design Engineer II

Key Responsibilities

• Design and develop medical device components, assemblies, and fixtures using Computer-Aided Design (CAD) tools such as SolidWorks.
• Build and test prototypes to evaluate design feasibility, functionality, and manufacturability.
• Collaborate with cross-functional teams, including manufacturing, clinical development, and quality engineering, to ensure product design alignment across the full development cycle.
• Prepare detailed design documentation, including engineering drawings, models, and design review materials.
• Apply Geometric Dimensioning and Tolerancing (GD&T) to ensure precision in component and assembly designs.
• Conduct product verification and validation testing, documenting results and implementing design improvements.
• Conduct design analyses and participate in risk assessments to ensure compliance with medical device regulations and standards.
• Participate in process development to ensure seamless transition from design to production.
• Add about machine/equipment troubleshooting and documentation

Position Requirements

• Bachelor’s degree in mechanical, industrial, or manufacturing engineering, or equivalent.
• Up to three years of relevant engineering experience in product design, prototyping, or process development.
• Proficiency with CAD software such as SolidWorks for 2D and 3D modeling.
• Understanding of GD&T and engineering documentation standards.
• Experience creating and testing prototypes using hands-on tools and fabrication techniques.
• Strong analytical and technical problem-solving skills.
• Excellent communication, organization, and documentation abilities.
• Ability to work collaboratively in cross-functional teams and operate independently when required.

Preferred

• Experience in medical device design, manufacturing, or regulated industry environments.
• Knowledge of surgical procedures, minimally invasive technologies, or clinical applications.
• Familiarity with FDA and ISO 13485 quality systems and design controls.
• Exposure to Failure Mode and Effects Analysis (FMEA) and Test Method Validation (TMV).
• Experience with Finite Element Analysis (FEA), tolerance analysis, or statistical analysis using Minitab.
• Exposure to Product Lifecycle Management (PLM) systems such as NetWeaver.

Benefits

• Competitive compensation range: $71000 - $95000 / year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Educational reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.