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Job Details

Job Summary:

Support the quality system by ensuring compliance to and enforcing regulations, standards, policies, standard operating procedures, and instructions related to design control of Haemonetics products. Effective member of assigned cross-functional design teams supporting new product development and sustaining engineering change management.

Essential Functions:

SUPPORT NEW PRODUCT DEVELOPMENT & PRODUCT CHANGE MANAGEMENT PROJECTS BY:

• Represent Quality department as cross-functional team member for product portfolios, new product development projects, and product change projects

• 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

  • 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

• Ability to support multiple Product Line Portfolios

• Provide quality engineering support for process development, implementation, improvement and validation efforts as assigned

• Provide Post Market Surveillance complaint investigation technical support

SUPPORT QUALITY SYSTEM BY:

• 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 as required

• Ensuring compliance to and enforcement of applicable regulations, standards, Haemonetics policies / procedures

Qualifications:

• Minimum of 3 years medical device or IVD product development and design quality engineering experience
• B.S. in Biomedical, Mechanical, Electrical or other appropriate Engineering degree.
• Good working knowledge of medical device design control process including risk management and design transfer
• Strong team collaboration with ability to handle multiple tasks in a fast pace new product introduction environment.
• Manufacturing process validation knowledge and experience
• Familiar with medical device Quality Management Systems

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