Product Development Engr 3

Soho Square Solutions; San Diego (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Soho Square Solutions in California is seeking an R&D Engineer to drive medical device infusion preparation and delivery hardware through design control and DFSS practices. You will develop design inputs, run feasibility studies, create verification protocols, and transfer designs to manufacturing while supporting global regulatory filings.

This on-site role in Brea, CA requires collaboration with cross-functional teams and strong engineering fundamentals.

Qualifications

• BS in Mechanical, Materials, or Biomedical Engineering.
• 5 years of experience or 3 years with advanced degree.
• SolidWorks or equivalent CAD tool.
• Experience with medical device design control processes.
• Ability to manage multiple projects in parallel.
• Ability to work in cross-functional teams.

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

Critical thinking

Multi-project management

Cross-functional teamwork

Team leadership

Strong communication

Education

BS - Mechanical Engineering, Materials Engineering or Biomedical Engineering

Tools

SolidWorks

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

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.