Control Design Engineer – medical compliance (f/m/x)

In the R&D Samplers Hardware Team, we are supporting product life cycle projects related to the Samplers product design from the perspective of quality and delivery. Our goal is to maintain current products on the market and support future strategic initiatives. This includes but is not limited to working with CAPAs, complaints, quality issues, external suppliers and services, including plastic molding, manufacturing support, capacity and yield improvement, obsolescence, compliance with standards & regulations, market access, and cost improvement projects. We are a team of experienced engineers working on a wide variety of tasks within the strictly regulated medical field. Our tasks often require a holistic approach and cross-functional alignment. We very much value being open-minded and ready for exploring new areas.

Your tasks
• Maintaining product documentation
• Running individual tasks from Samplers' daily management board from start to finish
• Running projects as a lead person and executing on tasks being part of bigger projects within Samplers
• Initiating and coordinating engineering changes (ECR/ECO)
• Designing and documenting a feasibility study testing
• Conducting cross-functional discussions and alignments
• Documenting your work in the form of impact assessments, technical rationales

Requirements
• Engineering background (M.Sc.) in Mechanics, Materials Science, Biochemistry, Biomedical engineering, or similar
• Minimum 5 years of experience in a similar position in medical / pharma industry
• Good understanding of Design Control principles
• Knowledge of medical standards and regulations and their applicability to different markets
• Experience in working with product-related documentation
• Expert skills in MS Office
• Basic knowledge in statistics
• Strong analytical skills (collaboration, creativity, critical thinking, data analysis, problem solving, research)
• Ability for business travelling mainly to the Stargard site (max 2-3 days/month)
• Fluent English in speaking & writing
• Fluent Polish required
• Residing in Poland required