Position will be required to be in the onsite (lab and office) more than 80% of the time in Brea, CA.

Manager's Update:

Job Summary

The Product Development Engineer III will support product development activities through hands-on engineering, testing, test method development and validation, data analysis, and technical documentation. The role requires an engineer who can contribute to product development projects, support design changes, and collaborate with senior engineers and cross-functional teams.

Candidates with experience in medical devices, healthcare, or other regulated industries are preferred. The ideal candidate is proactive, technically capable, and comfortable working in a collaborative environment.

Location: Brea, CA | Hybrid – 4 days onsite, Fridays remote

Core Responsibilities

• Develop, execute, and validate test methods to support product development activities.

• Perform product testing, analyze results, and interpret technical data.

• Develop test protocols, prepare technical reports, and maintain supporting documentation.

• Support product development activities involving design changes and process development.

• Update and maintain engineering drawings and related technical documentation.

• Support design control activities and follow established engineering and documentation procedures.

• Collaborate with senior engineers and cross-functional teams to resolve technical challenges.

• Take ownership of assigned engineering tasks and help advance product development projects.

Must-Have Qualifications

• Bachelor's degree in Mechanical Engineering or a related engineering discipline.

• Approximately 3–8 years of relevant engineering experience; exceptional candidates with less experience may be considered.

• Hands-on experience in product development, testing, test method development, or test method validation.

• Experience preparing test protocols, technical reports, and analyzing test data.

• Ability to independently execute technical assignments and contribute to product development activities.

• Experience working in a regulated industry, preferably healthcare or medical devices.

• Strong problem-solving skills, enthusiasm, and the ability to work collaboratively.

• Willingness to work onsite in Brea, CA, four days per week.

Nice-to-Have Qualifications

• Medical device product development experience.

• Experience with design control processes and engineering documentation.

• CAD experience, including SolidWorks, Pro/Engineer, or similar software.

• Experience updating engineering drawings and supporting design changes.

• Experience in healthcare, pharmaceutical, or other regulated environments.

• Statistical analysis experience, particularly for more experienced candidates.

• Startup experience or exposure to multiple engineering responsibilities.

Additional consideration: Candidates with strong CAD and product development experience but limited testing experience may also be considered. Relevant hands-on experience is more important than the exact number of years.

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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.

Required Qualifications:

• BS – Mechanical Engineering, Materials Engineering or Biomedical Engineering
• Work experience 5 years or 3 years plus an advanced degree
• Critical thinking – able to work with moderate guidance in own area of knowledge.
• SolidWorks or equivalent CAD tool
• Ability to manage multiple projects of varying scopes in parallel
• Ability to work leading or as part of a cross-functional team with members from marketing, sales, clinical, regulatory, medical affairs, quality, manufacturing, etc.
• Experience with medical device design control processes and creating and maintaining design control documentation.