The Design Quality Engineer II will be responsible for (in regards to product development):

• Support detail tracking through project deliverables such as project quality plans and safety assessments and perform updates and release to documents within the electronic system
• Participate in translation of Voice-of-Customer into development Requirements
• Responsible for the development, update, and release of various risk management documentation
• Support development team in the creation, review, and approval of:
• Engineering Requirements & Specifications
• Engineering test protocols and reports required for design verification, design validation
• Define statistical sampling and testing methods required for verification and validation testing and provide measurement analysis support as required
• Ensure accuracy and completeness of the Design History File and the Device Master Record
• Provide Post Market Surveillance complaint investigation technical support

The Design Quality Engineer II will be responsible for (in regards to QMS support):

• Leading or participating in continuous improvement projects as well as improvements to policies, procedures, instructions, and training
• Ensuring the ongoing readiness of the Quality Management System for external and internal audits and participating in audits and inspections
  

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Design Quality Engineer II Requirements are as followed:

• Minimum of 3 years medical device or IVD product development and design quality engineering experience
• Excellent Organization skills
• B.S. in Biomedical, Mechanical, or other appropriate Engineering degree.
• Good working knowledge of medical device design control process including risk management and design transfer
• Manufacturing process validation knowledge and experience

Our client is a global supplier of blood collection and separation technologies, surgical blood salvage systems, diagnostic products, software and information technology platforms, and consulting services.

The Design Quality Engineer II can expect competitive salary, compensation, bonus incentives and a brand new multi level facility in the heart of the city of Boston.