Quality Engineer 3

Our Global Team: We are a team of 66000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what s possible in healthcare to help improve people s lives around the world. As a leader in the industry we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care is crucial for clinical decision-making and treatment pathways.

Our Culture: We are part of an incredible community of scientists clinicians developers researchers professionals and skilled specialists pushing the boundaries of what s possible to improve people s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Do you want to join us in helping to fight the world s most threatening diseases and enabling access to care for more people around the world At Siemens Healthineers we pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

We are currently looking for an ambitious Senior Design Quality Engineer (Consumables) to join our Endovascular Robotics business within Advanced Therapies. We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics image guidance and dedicated devices will change the way neurovascular procedures will be done in the future enabling better outcomes and enabling our customers to provide better access to care.

This is a role well suited to an ambitious professional looking for the next step in their career. As a Sr Design Quality Engineer (Consumables) you will be responsible for:

New Product Development
Act as a Quality subject matter expert supporting the development of sterile single-use medical devices with ownership of packaging sterile barrier systems sterilization and biocompatibility considerations to ensure compliance with applicable standards and internal quality system requirements.
Support risk management activities in accordance with ISO 14971 including identification analysis mitigation and documentation of risks throughout the design lifecycle within the Risk Management File.
Support the development of Use Design and Process FMEAs to systematically identify and address potential failure modes and ensure appropriate risk controls are implemented.
Support design verification and validation activities including development review and approval of test plans protocols and reports with a focus on compliance testing for biocompatible sterile single-use consumable products (e.g. ISO 10993 IEC 60601-1 packaging and sterilization-related testing).
Support the development and maintenance of the Usability Engineering File in accordance with IEC 62366 and applicable regulatory requirements.
Support supplier qualification and process validation activities including review of supplier documentation and quality outputs.
Support test and inspection equipment evaluation method development and qualification activities as required.
Support manufacturing transfer activities including creation and review of DMR/DHR documentation and execution or review of validation protocols (IQ OQ PQ).
Develop review and maintain work instructions manufacturing procedures and inspection documentation to ensure alignment with validated processes and design requirements.
Sustaining Activities

Support the collection analysis and trending of quality and performance metrics to identify opportunities for improvement.
Propose lead and support Corrective and Preventive Actions (CAPAs) to address systemic issues and ensure effective resolution.
Lead and/or participate in product complaint investigations including root cause analysis and documentation of findings.
Support the disposition of nonconforming material including collaboration with cross-functional teams to determine appropriate actions.
Support other quality-related activities as assigned.

Required/Preferred skills to have for the success of this role:

Bachelor s degree in Engineering Biomedical Engineering or Life Sciences.
5 7 years of experience as a Quality Engineer or Design Quality Engineer in the medical device industry supporting development and sustaining activities for sterile single-use consumables and packaging.
Hands-on experience with ISO 10993-1 ISO 11607-1 and ISO 11135 preferred.
Working knowledge of QMSR ISO 13485 ISO 14971 IEC 62366 and MDD/MDR requirements.
Experience with applied statistics including use of Minitab or equivalent statistical software.
Demonstrated experience in CAPA nonconformance management and complaint investigations.
Experience supporting De Novo and/or PMA submissions is preferred.
Strong verbal and written communication skills with the ability to author clear concise and technically sound procedures protocols analyses and reports and to collaborate effectively with internal and external stakeholders.

At Siemens Healthineers we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

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As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. (use your country EEO required language where applicable)