San Jose, CA

Position Summary: Perform design and development projects for medical devices in support of company’s strategic plan.  Responsible for initiation and completion of development projects on time and with-in budget.  

Authorities:

• Has authority to control design and release of product to production to ensure optimum quality, complete documentation, and verified performance.

Duties and Responsibilities:

• Design and develop product(s) in full compliance with the company’s Design Control requirements and consistent with FDA QSR, ISO, MDD, CE Mark, and Canadian Medical Devices Regulations.
• Responsible for ensuring proper documentation consistent with company’s quality system.
• Responsible for knowing and planning activities consistent the company’s quality policy and quality objectives.
• Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP.
• Apply engineering knowledge and managerial skills to the design and develop new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost.
• Responsible for Good Manufacturing Practices, international compliance standards, and company procedures.
• New product testing, including comparison testing with competitor products, bench testing, animals testing and human testing, and including protocol and test report documentation.
• Responsible for overall verification efforts.
• Responsible for all project documentation.
• Participate in Design Reviews.
• Responsible for compliance with QSR Design Control.
• Support sales and marketing, clinical and regulatory efforts.  

Position Requirements: 

• Word, Excel, Project, SolidWorks and PowerPoint or equivalent required.    
• Ability to work independently, investigate, troubleshoot and resolve issues. 
• Experience with ISO/CE certification desired. 
• Working knowledge of current FDA Quality Systems Regulation, emphasizing Design Control.
• Excellent communications, personnel management, and time management skills required.
• Extensive knowledge of company products and business strategy required.

Education Requirements:

• BS Engineering Degree

Experience Requirements:

• Minimum 3+ years prior experience in medical product development or 5 years other product development experience.