Design Control Specialist (R&D) – Praca Poznań Sady, Tarnowo Podgórne

Lina Medical; Poznań; Hybrid; PLN 120,000 - 190,000; Full time

Job summary

Lina Medical is seeking a Design Control Specialist to join the R&D team. The role focuses on managing design control activities across the product development lifecycle to ensure regulatory compliance and adherence to quality standards.

You will support QA aspects in development and sustain existing products, lead risk management and design verification/validation efforts, and collaborate with regulatory officers, clinical experts, and suppliers to ensure robust documentation and compliance.

Qualifications

• Minimum 5+ years of experience in medical device design control, regulatory affairs, or quality engineering.
• Strong understanding of design processes, regulatory requirements, and quality management systems.
• Proficiency in risk management methodologies and tools.

Responsibilities

• Participate in R&D projects for new medical devices and maintain released products from a quality perspective.
• Lead activities such as risk management, usability, design verification & validation.
• Engage in problem solving, root cause analysis, NC & CAPA processes.

Skills

Design control

Regulatory affairs

Quality engineering

Risk management

Project management

Job description

The Design Control Specialist within the Research and Development (R&D) team plays a key role in managing design control activities throughout the product development lifecycle. This position is responsible for ensuring successful execution of design control processes, compliance with regulatory requirements and adherence to quality standards.

Responsibilities:

Participation in R&D projects for new medical devices development and maintenance of released products with following duties:

• Responsibility of QA aspects in development phase of new projects and sustaining already manufactured products from quality perspective
• Leading role in activities like risk management, usability, design verification & validation
• Involved in problem solving activities, root cause analysis, NC & CAPA processes
• Work in line with Quality Management System procedures and international standards and regulations, relevant for Medical Devices (like ISO 13485, FDA 21 CFR 820.30, MDR 2017/745, ISO 14971)
• Analyzing state of the art for similar products and defining input requirements for projects, in line with relevant safety product standards
• Participation in designing and executing pre-clinical tests
• Preparation of quality and technical documentation related to design development, testing, and regulatory purposes
• Cooperation with project teams, clinical experts, regulatory officers, technical consultants and suppliers
• Reporting to line manager and project manager

Requirements:

• Minimum 5-years? experience in medical device design control, regulatory affairs, or quality engineering.
• Strong understanding of design processes, regulatory requirements, and quality management systems.
• Proficiency in risk management methodologies and tools.
• Excellent communication, organization, and project management skills.
• Ability to work effectively in a cross-functional team environment and manage multiple priorities.
• Detail-oriented with a commitment to accuracy and compliance.

Please add the following clause: I consent to the processing of my personal data for the purposes of the recruitment process (in accordance with the Act of May 10, 2018 on the protection of personal data (Journal of Laws of 2018, item 1000) and in accordance with the Regulation of the European Parliament and Council (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46 / EC (GDPR)).