• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements
• Review, and approve design control deliverables such as requirements, specifications, validation protocols and reports to ensure compliance to customer and regulatory requirements.
• Review and approve human factors documentation such as use specifications, task analysis, formative and summative studies protocols and reports.
• Support Risk Management activities (RMP, HA, DFMEA, PFMEA, UFMEA and RMR).
• Support safety assurance case creation in compliance with the regulatory requirements.
• Provides guidance to cross-functional development team(s) in approach to design control documentation.
• Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
• Support design test and inspection method development, and lead method validation activities
• Responsible for establishing, communicating, and mitigating risk throughout the product development process
• Participate in design reviews
• Performs other related duties and responsibilities, on occasion, as assigned
Experience and Education:
• B.S. degree, in a scientific, technical, or engineering discipline.
• 5+ Years of experience in design controls and risk management
• Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and ISO 14971
• Must possess excellent oral and written communication skills, and the ability to communicate appropriately with cross functional teams
• Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter
• Ability to manage and prioritize multiple activities with varying business, compliance and customer drivers.
• Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations.
Andover MA: Sr Design Assurance Engineer (232086)