MedTech R&D Engineer – Product Development & DFSS

Insight Global; Brea (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Insight Global is seeking an experienced R&D Engineer to drive the development of intravenous infusion sets and related delivery devices. This role emphasizes design control, verification testing, and cross-functional collaboration across engineering, manufacturing, and regulatory teams.

The ideal candidate has a strong background in medical device development, hands-on lab work, and experience applying DFSS and DOE methods to transfer robust designs into production.

Qualifications

• BS in Mechanical, Biomedical, Materials Engineering, or related engineering field.
• 5+ years of relevant engineering experience, or 3+ years with an advanced degree.
• Medical device product development and design control experience.
• Experience with design verification/testing, including writing protocols and reports.
• DOE, statistics, or Design for Six Sigma (DFSS).
• Previous experience managing multiple R&D projects simultaneously.
• Strong hands-on mechanical engineering skills with the ability to work in a lab environment 80%+ of the time.

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

Hands-on engineering

Lab work 80%+

CAD - SolidWorks

Education

BS in Mechanical, Biomedical, Materials Eng or related field

Tools

SolidWorks

Job description

Insight Global is seeking an experienced R&D Engineer to drive the development of intravenous infusion sets and related delivery devices. This role emphasizes design control, verification testing, and cross-functional collaboration across engineering, manufacturing, and regulatory teams.

The ideal candidate has a strong background in medical device development, hands-on lab work, and experience applying DFSS and DOE methods to transfer robust designs into production.