Sr Design Assurance Engineer

Veranex • Providence, RI

47d

About The Position

About This Role: General Summary Responsible for accurate, independent generation and evaluation of risk management, design history file documentation and overall quality system compliance. Ensures compliance to customer and regulatory requirements and assists with the successful transfer of the design to manufacturing. Plans and leads execution of risk management on cross-functional product development teams.

Requirements

• Bachelor's degree in engineering or related field and 3-6 years of relevant work experience
• In-depth understanding of Food & Drug Administration (FDA) Quality System regulations, European Active Implantable & Medical Device Regulations, and relevant medical device principles
• Excellent written and oral communication skills
• Excellent attention to detail
• Ability to solve complex technical problems and manage multiple tasks and projects
• Must be able to author, revise, and review SOPs.
• Must be able to think creatively and provide guidance as to the best path forward for individual programs while maintaining the expectation of high-quality work and product while considering client and program needs. Ability to understand client needs, balanced with regulation, to set quality strategies for projects as tactical, key member of project leadership
• Extensive experience in Risk Management Planning, UFMEAs, DFMEAs, Engineering Verification Planning and Execution, Design Verification Planning and Execution, Measurement Systems Analyses, PFMEAs, Process Verification & Validation Planning and Execution, and Supplier Quality.

Responsibilities

• Leads risk management for novel and existing medical devices, including risk management plans and reports, hazard analyses and use, design, and process Failure Mode & Effects Analysis (FMEA).
• Provides input to development teams in the design of highly complex medical devices.
• Provides quality insight and leadership on program teams and assists with establishing appropriate build quality controls appropriate with use.
• Ensures the successful integration of quality assurance and regulatory compliance, working across multiple teams and medical device/equipment categories.
• Develops, documents, and validates inspection and test methods to support design control, in-process inspection, and final inspection activities.
• Reviews, assesses, and approves product design milestones and deliverables throughout product development cycle.
• Develops, documents, and validates inspection and test methods to support design control, in-process inspection, and final inspection activities.
• Assists with implementing and maintaining a quality system that is compliant with relevant quality system regulation requirements. Supports internal and external audit activities. Participates in Quality System continuous improvement activities.
• Mentors other engineers. Supports employee development and teambuilding.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 1,001-5,000 employees