Design Quality Engineer I

Design Quality Engineer I

Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

Your responsibilities will include:

• Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier.
• Generates and maintains incoming inspection procedures. Trains inspectors to these procedures.
• Develops and/or sources inspection tools and equipment.
• Assists in generating component specifications.
• Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products.
• Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.
• Analyses incoming material defects. Dispositions and drives corrective action as necessary. Communicates issues to suppliers.
• Reviews new design specifications and provides input from component quality and manufacturability perspective.
• Investigate field failures related to supplier materials. Develop corrective action plan where necessary.
• May supervise inspectors.

Required qualifications:

• Bachelors degree in Electrical Engineering
• Must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization
• 0-1 years of prior experience (or similar through internships/co-ops) in Quality Engineering
• Prior internship experience with Boston Scientific

Preferred qualifications:

• Previous Software Design Assurance or related experience is a plus
• Medical device or other regulated industry experience
• Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304)
• Experience with Software code reviews
• Experience with Issue Tracking Tools (Jira) and Requirements/ Test Management Tools
• Knowledge of Cybersecurity and Cloud Computing concepts
• Knowledge of Artificial Intelligence/ Machine Learning concepts