JOB DESCRIPTION

• Contribute to sustaining engineering and design change projects by updating and reviewing requirements and documentation
• Support IVDR review cycles, design reviews, requirement updates, trace matrices, risk assessments, verification plans, and test protocols/reports
• Identify risks and propose mitigations for incorporation into projects
• Coordinate work across project teams and related groups
• Communicate effectively with culturally diverse audiences and all organizational levels
• Maintain compliance with Haemonetics Quality System processes and work instructions

REQUIRED SKILLS

• 3–5 years of requirements management experience
• Requirements writing experience
• Critical thinking and problem-solving skills
• Collaborative, team-oriented personality
• In vitro diagnostic experience
• Medical device and design controls experience
• Innovative thinking with strong problem-solving skills
• Familiarity with risk management processes

PREFERRED SKILLS

• DOORs (IBM) experience
• Project coordination
• Trace matrices
• Verification and validation process experience
• Experience with companies such as Company, Abbott, or Boston Scientific

EDUCATION REQUIREMENTS

• Bachelor’s degree in a related science or engineering field preferred

• Review and update plans, reports, labeling, user needs, system requirements, and trace matrices as needed
• Manage and monitor execution of R&D quality plans and resolution of non-conformances
• Support updates to requirements, risk assessments, and associated documentation for impacted products