Job Description
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Varian Medical Systems, a Siemens Healthineers company is seeking a Test Engineering Manager to join our Interventional Oncology (IO) development team. The individual will be a member of our growing embolization product development team that is focused on treating cancers by delivering internal chemical/radiation therapy and occluding the blood supply to tumors. The individual would contribute by leading the testing aspects of design and development related to new implantable therapy and embolization products, as well as managing a team of laboratory technicians. The ideal candidate would be a self-driven individual with a passion for medical device development and a desire to work on products that change people’s lives. What You Will Do Develop and execute complex test plans involving significant data collection and interpretation, assessment of results, and incorporation of step for continuous design improvements Lead coordination with external testing agencies and laboratories to evaluate devices Support design and development of novel chemical and materials-based devices, including chemical (XRD, DSC, leachable, etc), radiation-related, and mechanical (stiffness, sizing, etc) assessments Develop validated methods for process development and production needs for both internal and external testing Write technical documentation including process descriptions and test methods Lead the R&D team of laboratory technicians including hiring, performance management, and training Manage technician resources within and across projects to reach program goals Provide technical leadership and guidance to the project team Mentor technicians in best practices Contribute to and maintain FDA compliant Design History Files (DHF) Execute test processes as they relate to quality system compliance with FDA 510(K), QSR and ISO 13485 Participate in complaint investigations, and failure analysis of products Provide root cause analysis support and drive the implementation of corrective action for process-related issues Perform other duties as assigned or required What You Will Have Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Materials Science, or a related technical field 5+ years of experience in test engineering, materials characterization, or laboratory-based product testing 2+ years of experience leading, mentoring, or supervising laboratory or engineering staff Hands-on experience with chemical, materials, and/or mechanical testing and test method development or validation Experience managing or coordinating work with external testing laboratories or vendors Working knowledge of regulated product development environments (e.g., FDA, ISO 13485, QSR, or similar) Experience supporting design verification and validation activities Ability to work effectively within a documented Quality System Strong organizational skills with attention to detail and data quality Effective communication skills, both written and verbal What Will Set You Apart Master’s degree or PhD in a relevant engineering or scientific discipline Experience developing or testing regulated medical devices and/or combination products Exposure to radiation-based testing or evaluation methods Prior laboratory or engineering management experience within a medical device or similarly regulated industry #LS-OS1 Who we are : We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare.