Product Development Engineer 3

Sunrise Systems, Inc.; San Diego (CA); Presencial; USD 100.000 - 140.000; Jornada completa

Descripción de la vacante

Sunrise Systems, Inc. seeks a motivated R&D Engineer to lead medical device design control activities for intravenous infusion sets and related products. You will develop technical plans, perform feasibility studies, and transfer designs to manufacturing.

The role requires collaboration across functions, expert communication, and hands-on lab work in our Brea, CA facility, with frequent design verification and documentation to support regulatory filings.

Formación

• BS – Mechanical Engineering, Materials Engineering or Biomedical Engineering.
• 5 years of work experience or 3 years plus an advanced degree.
• Experience with medical device design control processes and creating and maintaining design control documentation.

Responsabilidades

• 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.

Conocimientos

Critical thinking

SolidWorks

Project management

Cross-functional teamwork

Design controls

Educación

BS in Mechanical Engineering

BS in Materials Engineering

BS in Biomedical Engineering

Herramientas

SolidWorks

Descripción del empleo

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