Product Development R&D Engineer

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

Job Description

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.

Skills and Requirements

• 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 experienceExperience with IV sets, infusion systems, connectors, catheters, disposables, or similar medical devices

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [e-mail].