Systems Engineer

Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people.Job Title: Systems Engineer About the opportunity: We are seeking a skilled and detail-oriented Systems Engineer to support the development and lifecycle management of medical device software products. This role focuses on translating user needs into system requirements, maintaining design control documentation, and contributing to risk management activities in collaboration with cross-functional teams. You will work closely with internal stakeholders and external development partners to ensure compliance with regulatory standards and alignment with user experience goals.Location: Warsaw – hybrid (8 days on-site monthly)What you will do: Perform Systems Engineering Requirements Identification and Traceability, including collaboration with cross-functional teams such as Commercial, Regulatory, Quality, Medical, Legal, and Engineering.Conduct medical device risk assessments using tools such as hazard analysis and Failure Mode and Effects Analysis (FMEA).Review supplier risk assessments to ensure alignment with product safety and regulatory expectations.Maintain Medical Device Design History File elements, including Design Inputs, Design Outputs, and Design Verification documentation.Assess the impact of changes to Design Control deliverables for marketed medical devices and medical device software products.Review user experience (UX) and user interface (UI) design deliverables for medical device software and translate them into system requirements and user stories.Coordinate medical device software project management activities in collaboration with external development teams. What you need for success: 3–5 years of experience in systems engineering is required.A degree in Engineering or Computer Science is required.Full proficiency in English is required.Experience with change management is preferred.Previous experience in software project management is preferred.Familiarity with Agile or hybrid agile/iterative development processes is preferred.Experience with medical devices is an advantage. What we can offer you:Friendly team and a supportive work environmentEmployment contract with a hybrid work modelOne-time allowance for home office setupMonthly lunch card worth 320 PLNAnnual performance-based bonusLife insurance and private medical care (Luxmed VIP package with dental coverage)Pension Plan (PPE) and Employee Assistance ProgramMulticafeteria benefits (e.g., sport card, cinema tickets)Access to LinkedIn Learning with a wide range of training coursesOnline language learning via eTutorAccess to an audiobook platformTO ALL RECRUITMENT AGENCIES: Ascensia does not accept unsolicited third-party resumes.Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.