Design Quality Engineer - Clinton, PA

Haemonetics • Clinton, PA

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About The Position

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. 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

Requirements

• 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

Responsibilities

• 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees