Product Development Engineer - Medical Device

Job Title: Product Development Engineer

Location: Brea, CA, 92821

Duration: 12 Months

Job Description

We are seeking a driven and passionate R&D Engineering Lead to join our Infusion Preparation and Delivery (IPD) platform. As a key member of our team, you will be responsible for leading the development and lifecycle management of intravenous infusion sets and connection devices. Your role will involve collaborating within a cross-functional team to drive technical strategies, engineer robust products, and ensure adherence to rigorous engineering practices and design control processes.

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.
• Engineer robust products through a strong understanding and application of engineering fundamentals and DFSS principles.
• Develop technical plans and guide the team to develop design inputs, conduct feasibility studies, refine product designs, verify and validate subsystems, transfer designs alongside Manufacturing, and provide design documentation for regulatory filings.
• Execute design verification testing to confirm design outputs meet requirements.
  
  

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Materials Engineering, or Biomedical Engineering.
• Minimum of 5 years of work experience in engineering, or 3 years plus an advanced degree.
• Proficiency in SolidWorks or equivalent CAD tool.
• Familiarity with medical device design control processes and documentation maintenance.