Medical Device R&D Engineer – IPD & DFSS (Onsite CA)

Soho Square Solutions; San Diego (CA); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Soho Square Solutions in California is seeking an R&D Engineer to drive medical device infusion preparation and delivery hardware through design control and DFSS practices. You will develop design inputs, run feasibility studies, create verification protocols, and transfer designs to manufacturing while supporting global regulatory filings.

This on-site role in Brea, CA requires collaboration with cross-functional teams and strong engineering fundamentals.

Competenze

• BS in Mechanical, Materials, or Biomedical Engineering.
• 5 years of experience or 3 years with advanced degree.
• SolidWorks or equivalent CAD tool.
• Experience with medical device design control processes.
• Ability to manage multiple projects in parallel.
• Ability to work in cross-functional teams.

Mansioni

• 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

Conoscenze

Critical thinking

Multi-project management

Cross-functional teamwork

Team leadership

Strong communication

Formazione

BS - Mechanical Engineering, Materials Engineering or Biomedical Engineering

Strumenti

SolidWorks

Descrizione del lavoro

Soho Square Solutions in California is seeking an R&D Engineer to drive medical device infusion preparation and delivery hardware through design control and DFSS practices. You will develop design inputs, run feasibility studies, create verification protocols, and transfer designs to manufacturing while supporting global regulatory filings.

This on-site role in Brea, CA requires collaboration with cross-functional teams and strong engineering fundamentals.