Design Control Specialist (R&D)

About the role

LiNA Medical Polska, a manufacturer of minimally invasive gynecological medical devices, is looking for a Design Control Specialist (R&D) in Poznań. The position is full-time and reports to the line manager and project manager. The recruitment has ended and the listing is now archived.

Key responsibilities

• Take part in R&D projects for new medical devices and maintain released products
• Handle QA aspects during development of new projects and sustain existing products from a quality perspective
• Lead risk management, usability, design verification and validation
• Take part in problem solving, root cause analysis, non-conformity and CAPA processes
• Work according to QMS procedures and international standards such as ISO 13485, FDA 21 CFR 820.30, MDR 2017/745 and ISO 14971
• Analyse the state of the art of similar products and define input requirements for projects
• Take part in designing and running pre-clinical tests
• Prepare quality and technical documentation for design development, testing and regulatory purposes
• Cooperate with project teams, clinical experts, regulatory officers, technical consultants and suppliers

Required profile

• At least 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
• Excellent communication, organisation and project management skills
• Ability to work in a cross-functional team and manage several priorities
• Detail-oriented, committed to accuracy and compliance
• English at B2 level or higher (speaking, reading and writing)

Required skills

• Proficiency in risk management methodologies and tools
• Knowledge of ISO 13485, ISO 14971 and MDR

What we offer

• A supportive, collaborative environment with a dedicated team
• Opportunities for professional growth and internal and external training
• Private medical care, sports card, flexible working hours and home office
• Co-financing for English language courses and fruit and snacks