Sr Design Quality Engineer at Corindus, Inc. in Newton, Massachusetts

Job Description:

Our Global Team : We are a team of 66,000 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 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, you will be responsible for:


New Product Development-

• Representing the Quality Department as a subject matter expert in Design Control within cross-functional teams assisting in the development, review, and approval of traceable design inputs/outputs.


• Participating in the development of medical device software compliant with IEC-62304 and relevant regulations.


• Leading risk assessment and ensuring that risks are identified, analyzed, and mitigated in accordance with ISO-14971 throughout the design process and compiled in the Risk Management File.


• Leading the development FMEA (Use, Design, Software, Process) to systematically address potential failure mode.


• Supporting the development of the Usability Engineering File in accordance with IEC-62633 and applicable regulations.


• Supporting the suppler qualification and classification process.


• Supporting design verification and validation activities by assisting in the development and review of test plans, protocols, and reports, including specific compliance testing (e.g., IEC-60601-1, ISO-10993-1, etc.)


• Assisting in test and inspection equipment evaluation and subsequent method qualification.


• Assisting in the manufacturing transfer process including the creation and completion of planning documentation, DMR/DHR, and validation protocols (IQ, OQ, PQ).


• Supporting other duties as assigned by manager.

Sustaining Activities-

• Supporting the collection and analysis of performance metrics.


• Proposing and leading Corrective and Preventive Actions (CAPAs).


• Leading and/or participating in product complaint investigations leading to root cause.


• Assisting in the dispositioning of non-conforming material.


• Supporting other duties as assigned by manager.

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

• Bachelor's degree required in Engineering, Biomedical Engineering, or Life Sciences.


• Minimum of 8 to 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical Class III devices is required.


• Working knowledge of QSR, MDD/MDR, ISO-13485 and ISO-14971 is required.


• Experience supporting the development of compliant medical device software or SaMD (i.e, IEC 62304/82304) and SWFMEA development is required.


• Experience in applied statistics including use of Minitab or other statistical analysis software is required.


• Experience in CAPA, NCMR, complaint investigations is required.


• Familiarity with electrical component handling and ESD controls is required.


• Experience with single use consumable development and specific experience with ISO 10993-1 :2018, ISO 11607-1:2019, ISO 11135:2014 is preferred.


• Experience with supporting De Novo/PMA submissions is preferred.


• Effective and professional communication skills with both internal and external stakeholders.


• Effective written communication skills, with the ability to author clear, concise, and accurate procedures, analyses, protocols and reports.


• Effective time/task management skills; excel working in a fast-paced environment.

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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If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.


If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.


As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.


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