R&D Product Development Engineer

Insight Global; Brea (CA); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Hands-on engineering

Lab work 80%+

CAD - SolidWorks

Formation

BS in Mechanical, Biomedical, Materials Eng or related field

Outils

SolidWorks

Description du poste

• 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
• SolidWorks or similar CAD experience
• Strong hands-on mechanical engineering skills with the ability to work in a lab environment 80%+ of the time

Strong Plusses

• Experience with IV sets, infusion systems, connectors, catheters, disposables, or similar medical devices
• Experience supporting regulatory submissions

Research and Development Engineering is responsible for development and lifecycle management of products through medical device design control processes and good engineering and documentation practices. The Infusion Preparation and Delivery (IPD) platform seeks a hardworking and passionate Engineer to develop and drive technical work for Product. Ideal candidate demonstrates working knowledge of Engineering principles and its application in solving standard technical problems and working knowledge of product design, development, and design control process. Develops technical plans for design inputs and outputs, conducts analytical and empirical feasibility studies, develops test methods to verify and validate subsystems and systems in order to transfer designs alongside Manufacturing. Demonstrates knowledge to provide design documentation to support global Regulatory filing strategies. Applies basic statistical techniques and utilizes design of experiments with moderate guidance. Collaborates within a cross-functional team to plan, develop, modify, implement, and support IPD products through the application of rigorous engineering practices. Works with moderate guidance to achieve project objectives.

R&D engineers are responsible for leading and supporting projects as part of a cross-functional global team. This is a highly collaborative position and requires excellent leadership, verbal, and written communication skills. Projects will involve requirements definition, developing test methods, writing test protocols, reports, executing verification testing, solving test or design issues and other types of mechanical engineering activities.

Job 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.