Medical Device Design Control Specialist – R&D

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

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.