Design Assurance Engineer

Description

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

Requirements

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

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance