R&D Engineer, Medical Devices — Design Control Lead

Sunrise Systems, Inc.; San Diego (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Sunrise Systems, Inc. seeks a motivated R&D Engineer to lead medical device design control activities for intravenous infusion sets and related products. You will develop technical plans, perform feasibility studies, and transfer designs to manufacturing.

The role requires collaboration across functions, expert communication, and hands-on lab work in our Brea, CA facility, with frequent design verification and documentation to support regulatory filings.

Qualifications

• BS – Mechanical Engineering, Materials Engineering or Biomedical Engineering.
• 5 years of work experience or 3 years plus an advanced degree.
• Experience with medical device design control processes and creating and maintaining design control documentation.

Responsibilities

• Lead R&D deliverables throughout the medical device design control process for intravenous infusion sets and connection devices.
• Collaborate within a cross-functional team to plan, develop, modify, implement, and support IPD products through the application of rigorous engineering practices.
• Engineer robust products through strong understanding and application of engineering fundamentals and DFSS principles.
• Develop technical plans and guide the team to develop design inputs, conduct analytical and empirical feasibility studies, refine product configurations and designs, verify and validate subsystems and systems, concurrently transfer designs alongside Manufacturing and Operations, and provide design documentation to support global Regulatory filing strategies.
• Execute design verification testing to confirm design outputs meet design input requirements.

Skills

Critical thinking

SolidWorks

Project management

Cross-functional teamwork

Design controls

Education

BS in Mechanical Engineering

BS in Materials Engineering

BS in Biomedical Engineering

Tools

SolidWorks

Job description

Sunrise Systems, Inc. seeks a motivated R&D Engineer to lead medical device design control activities for intravenous infusion sets and related products. You will develop technical plans, perform feasibility studies, and transfer designs to manufacturing.

The role requires collaboration across functions, expert communication, and hands-on lab work in our Brea, CA facility, with frequent design verification and documentation to support regulatory filings.