Medical Device R&D Engineer – Infusion Systems

Insight Global; Brea (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Insight Global is seeking a skilled R&D Engineer to support the Infusion Preparation and Delivery platform, focusing on medical device design control and product development lifecycle.

The role involves leading verification testing, developing test protocols, and collaborating with Manufacturing and Regulatory teams to transfer designs and filing strategies. Strong leadership and communication are essential for success in a global team.

Qualifications

• BS in Mechanical, Biomedical, Materials Engineering or related field.
• Experience with medical device product development and design control.
• Design verification/testing experience, including writing protocols and reports.
• DOE, statistics, or Design for Six Sigma (DFSS).
• Experience managing multiple R&D projects concurrently.

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 engineering practices.
• Engineer robust products applying engineering fundamentals and DFSS principles.
• Develop technical plans and guide the team to create design inputs, conduct feasibility studies, verify and validate subsystems, and support regulatory filings.
• Execute design verification testing to ensure outputs meet inputs.

Skills

DOE

Statistics

DFSS

SolidWorks

Project management

Medical device development

Education

B.S. in Mechanical/Biomedical/Materials Engineering

Tools

SolidWorks

Job description

Insight Global is seeking a skilled R&D Engineer to support the Infusion Preparation and Delivery platform, focusing on medical device design control and product development lifecycle.

The role involves leading verification testing, developing test protocols, and collaborating with Manufacturing and Regulatory teams to transfer designs and filing strategies. Strong leadership and communication are essential for success in a global team.