Design Assurance Engineer

Overview

Ensures design compliance, verification, validation, and regulatory approval for new products.

Key Responsibilities

• test management
• design review
• method development
• statistical support
• tech transfer
• risk analysis

Tasks

-Manage test protocols, execution, issue investigation, and report analysis. -Participate in New Product Development Phase Reviews and lead or participate in Design Reviews. -Support in achieving regulatory approvals and addressing inquiries. -Assist in internal and external audits. -Develop and validate new test methods to meet design standards. -Collaborate with R&D to define and manage design inputs and outputs. -Manage statistical support for validations and sample sizes. -Review Electrical and Software Design Inputs and ensure Verification/Test Readiness. -Facilitate transfer from development to production. -Adhere to ethical standards, legal requirements, and company policies. -Ensure compliance with design controls, international standards, and FDA guidelines. -Work with R&D and external consultants for project deliverables. -Document risks through Hazard Analysis, DFMEA, PFMEA, UFMEA. -Implement product stability program. -Interact with contract manufacturers and suppliers. -Improve quality system deliverables and processes. -Conduct design verification and validation, including usability assessments.

Requirements

• design controls
• risk management
• engineering degree
• asq
• fda
• problem solving

What You Bring

-Understanding of design controls, risk management, statistics, and development processes. -Strong communication and technical writing skills. -Degree in Engineering, preferably Electrical or Software Engineering. -Ability to work independently, manage tasks, and lead teams. -ASQ certification. -Minimum of 2 years related experience or training. -Problem-solving capabilities. -Familiarity with FDA, QSR, and ISO requirements.

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About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

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