Digital Device Quality Expert – Samd

Digital Device Quality Expert – Samd

Requirements

• BS/M.Sc. or equivalent degree in science or engineering (e.g. software engineering, systems engineering, electrical engineering, or related engineering degree)
• Strong understanding of specified functional area, an equivalent combination of education and work experience.
• 4 years’ experience in medical device product development focused on quality engineering related activities.
• 2 + years relevant experience in risk management for medical devices
• Strong experience in software development and medical device life cycle management
• Good knowledge of and experience in performing safety and cybersecurity risk management for medical devices
• Proficient in usage of risk assessment methods, e.g.: Hazard Analysis (PHA), Software Risk Analysis, Fault Tree Analysis (FTA), Failure Modes and Effects Analysis (FMEA)
• Good knowledge of medical device regulations and international standards, e.g.: ISO 13485, 21 CFR 820, IEC 62304, ISO 14971, TIR 57, MDR, ISO/TR 80001, IEC TR 80002-1
• Language – Business fluent (written and oral) in English is required.

Responsibilities

• Represent Digital Device Quality on cross-functional teams in support of SaMD activities, collaboration with the internal and external stakeholders
• Plan for and provide appropriate Quality & Compliance support for the project and application portfolios of the SaMD Digital Health Technology teams
• Promote quality and compliance throughout the Product life cycle and implement processes, procedures and awareness and training on Quality Management System
• Provide quality engineering support for design and development, and facilitate the application of controls and risk management to ensure that SaMDs are designed to be safe, effective and in compliance with the applicable regulations worldwide.
• Work with cross-functional teams for, review and approval of design & development plans, requirements, specification development, engineering studies, design verification protocols and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.
• Lead and participate in design reviews
• Provide Quality impact assessment for product changes
• Provide quality input into CAPA and nonconforming product investigations
• Support root cause investigations and implementation of corrective actions
• Lead all risk management activities according to ISO 14971 and TIR 57
• Plan, prepare and perform risk management activities for medical devices according to project phases following all relevant internal procedures, processes and external requirements for development products.
• Ensure that all hazards, threats and vulnerabilities associated with a medical device are identified, the associated risks are estimated and evaluated and that these risks are controlled; monitors that these risk controls are implemented, verified and validated.
• Maintain a close link to the human factors engineering process to meet the needs and ensure the safety of all users and patients.
• Collaborate with Business Product owners, Quality and Digital teams to prepare for regulatory inspections and internal audits, respond to questions and address findings through corrective/preventive action plans to improve compliance and effectiveness of the quality management system
• Lead supplier evaluation and qualification, auditing supplier’s quality management system to applicable regulations and quality standards, providing metrics and addressing quality and regulatory issues.
• Author and maintain quality agreements.

Preferred Qualifications

• Excellent communication and presentation skills, to inform and persuade both in speaking and in writing.
• Ability to learn quickly and self-educate on different technologies/therapies as applicable to medical products and procedures (Self-starter attitude)
• A general understanding of the potential sources of risk providing solutions and how to manage them.
• 1 -2 years of supplier management experience preferred.
• Ability to enter into highly different cultural and regulatory backgrounds worldwide with diplomatic sensitivity
• Experience in Agile development principles and can work with at least one of the common frameworks.
• The ideal applicant will have experience in at least one or more of the following technical domains: Medical devices and systems, Mobile device application architecture and security, IoT (embedded) devices and systems, Cloud systems architecture and security, Large-scale application architecture and security, Data protection architectures for data at rest and in transit, AI and machine learning concepts.