Job Specification - Design Assurance Engineer

Position Overview
The Design Assurance Engineer will be instrumental in ensuring the quality, safety, and regulatory compliance of medical devices throughout the product development life-cycle. This role offers an exciting opportunity to contribute to groundbreaking advancements in healthcare within a fast-paced start-up environment.

Key Responsibilities

• Establish and maintain appropriate procedures to ensure compliance with regulatory requirements.
• Review/analyze whether current products and processes (including actions or decisions conducted) comply with standards such as the QSRs, ISO 13485, EU MDR, etc.
• Partners with R&D and other cross-functional partners to ensure the proper application of design controls, risk management, and the investigation/correction of design failures/challenges.
• Preparation of Standard Checklists for all the applicable regulatory standards.
• Performs Design Assurance activities including technical reviews of design documentation and labeling, attends design reviews, coordinates and facilitates completion and update of design risk management documentation.
• Assist when requested with the preparation of regulatory filings and subsequent correspondences on supporting submissions.
• Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to product development, manufacture and subsequent commercialization.
• Maintain detailed awareness and understanding of current regulations and regulatory guidance in regions of interest to development programs.
• Lead and support design control activities, including the development and maintenance of design plans, design inputs, design outputs, and design verification/validation protocols and reports.
• Conduct risk management activities, including the identification, assessment, and mitigation of design-related risks in accordance with regulatory requirements and industry standards.
• Plan, execute, and document verification and validation testing activities to demonstrate product performance and safety.
• Collaborate closely with cross-functional teams, including R&D, Regulatory Affairs, Clinical Affairs, and Manufacturing, to ensure alignment and coordination throughout the product development process.
• Maintain accurate and up-to-date design history files (DHF) and other design-related documentation in compliance with regulatory requirements.
• Identify opportunities for process improvement and drive initiatives to enhance design assurance practices and efficiency.

Requirements

• Bachelor's degree in engineering or a related technical field.
• Minimum of 3-5 years of experience in design assurance or quality engineering within the medical device industry, preferably with Medical devices.
• Strong understanding of design control principles and regulations, including FDA QSR (21 CFR 820) and ISO 13485
• Experience with risk management methodologies, such as ISO 14971, and application to medical device development.
• Proficiency in verification and validation testing techniques, including protocol development, execution, and documentation.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Detail-oriented with strong analytical and problem-solving abilities.
• Ability to work independently and manage multiple tasks simultaneously in a fast-paced, dynamic environment.

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