Remediation Engineer

Purpose

The Remediation Engineer will be responsible for identifying and resolving deficiencies in existing product documentation, particularly within Design History Files (DHFs), and product development processes to ensure compliance with regulatory standards and internal quality management systems.  The Remediation Engineer will lead process improvements and corrective and preventative actions (CAPAs) activities to address and resolve issues and prevent future problems by identifying and addressing noncomforties.

Responsibilities

• Conduct gap analyses of existing product documentation such as Design History Files (DHF) and other relevant documentation to identify gaps and non-compliances with quality procedures
• Conduct gap analyses of design controls, risk management, testing, sampling, verification and validation procedures to identify  gaps and implement corrective actions
• Develop and execute comprehensive remediation plan for corrective actions for any gaps or process improvement opportunities identified.  Develop a project timeline, identify required resources and responsible parties
• Identify and implement process improvements, including update to QMS documents, training, verification and validation practices to ensure ongoing regulatory adherence
• Standardize engineering procedures by developing and improving supporting processes, creating standard operating procedures (SOPs), and implementing best practices to enhance consistency across all product development teams
• Participate in risk management activities related to new product development and sustaining projects
• Assist with investigation of product quality events and corrective and preventative (CAPA) actions
• Design, develop, and implement engineering solutions for complex problems
• Collaborate with cross-functional teams to implement process improvements and resolve techncial challenges
• Mentor and train engineers, providing guidance on best practices for product design, testing, and manufacturing.  Support teams in improving technical documentation
• Review verification and validation activities, including the development of protocols, review of test data, and preparation of validation reports to ensure compliance with design and regulatory standards
• Author and revise standard operating procedures (SOP) according to FDA, AATB, and other regulations if applicable
• Assist in monitoring corrective actions post remediation to ensure continued compliance
• Collaborate across departments to align product requirements with company objectives and ensure seamless project execution
• Support Quality Assurance and Regulatory Affairs with regulatory responses, audits, or follow-up actions related to Design Controls, DHF\'s, and existing products
• Maintain a working knowledge of FDA 21 CFR 1271, FDA21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
• Maintain acceptable attendance and punctuality for scheduled work hours and meetings.  Ensure completion of assigned tasks and responsibilities within defined timeframes
• Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
• Perform other duties as assigned
• Travel domestically up to 10% to attend offsite meetings, conferences, and support business initiatives

Skills

• Strong understanding of medical quality systems, documentation, risk management and design control
• Strong verbal and written communication skills, including presentation skills
• Strong technical writing ability
• Knowledge of cleanroom manufacturing environments and validation procedures
• Strong analytical and creative thinking skills
• Ability to work in a fast-paced environment
• Abilit to work independently and in a team environment
• Excellent attention to detail and organization
• Proficiency in Microsoft Office

Qualifications/Requirements

• Bachelor\'s or master\'s degree in biomedical engineering, tissue engineering, mechanical engineering, or related field required
• 3 - 5+ years of medical device quality assurance and/or product development experience required
• Proficiency in human cell tissue-based products (HCT/Ps) and/or medical device design required
• Experience with product approvals and post market support
• Experience with material controls
• Proficiency in manufacturing and process controls
• Experience with FDA 21 CFR 1271, 21 CFR 820.30 Design Controls required
• Experience with allografts and/or medical devices required
• Clearance of favorable background investigation required