Engineering Manager: Hardware Testing for Medical Devices
MedTechPharmaClinical ResearchRegulatory AffairsQuality Assuranceheorgdpemafdaiso 13485croinform
Job description
We anticipate the application window for this opening will close on - 18 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Engineering Manager, Test Engineering will own the full end-to-end verification work for large capital hardware/software medical device. Inclusive of hardware, software, and integration testing. Lead a team of test engineers. A Day in the Life Across our global Neuroscience organization, we advance care for some of medicine's most complex neurological and spinal conditions. Cranial and Spinal Technologies (CST) is leading the way in surgical imaging and navigation, delivering solutions that improve outcomes and transform how surgeons work. Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE ™ connect these technologies to enhance surgical precision, streamline workflows, and support improved patient outcomes worldwide. Lead a group of test engineers working on design verification for the Platforms and Solutions portfolio of products (capital systems, clinical software applications, and associated surgical instruments) within the Cranial and Spinal Technologies (CST) operating unit. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include the following and other duties may be assigned: Plans, directs, and implements all aspects of the test strategy, design, and execution for hardware and software components of a large capital equipment imaging system (O-arm), including Software as a Medical Device (SaMD). Leads and manages a team of test engineers across design verification, test automation, and system integration testing activities. Owns and is accountable for on-time delivery of test milestones across multiple concurrent projects and releases throughout the product development lifecycle. Drives the development and adoption of test automation frameworks , to improve test efficiency, coverage, and repeatability. Guides the conceptualization of new test methodologies, automation strategies, and approaches to v erifying product behavior ; which may span virtual environments, physical labs, or both. Directs the development of test plans, protocols, and verification strategies from initial design through release, ensuring alignment with applicable regulatory, cybersecurity, privacy, and quality system requirements (e.g., FDA, IEC 62304, ISO 13485, ISO 14971, HIPAA, GDPR, SOC 2, as relevant to the product). Leads system integration testing activities, ensuring hardware and software components function correctly as an integrated imaging system. Selects, develops, coaches, and evaluates personnel to ensure efficient operation of the test function and the growth of technical talent within the team. Influences and collaborates with cross-functional teams including systems engineering, software engineering, hardware engineering, regulatory affairs, and quality. Provides technical leadership and mentorship to test engineers at all levels. Required Knowledge and Experience: Requires a Baccalaureate degree in Mechanical Engineering, Electrical Engineering, Computer Science, Biomedical Engineering, or a related engineering discipline (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)). A minimum of 5 years of relevant experience, or an advanced degree with a minimum of 3 years of prior relevant experience. Nice-to-Haves: Experience developing or testing Software as a Medical Device (SaMD) or software within a medical device context. Experience with test automation frameworks, specifically LabVIEW and TestComplete . Hands-on experience with system integration testing of complex hardware/software systems. Familiarity with x-ray or medical imaging system testing. Working knowledge of IEC 60601-1 and IEC 60601-1-2 electrical safety and electromagnetic compatibility standards. Experience with reliability demonstration of large capital equipment. Experience mentoring, developing, and growing peers and/or direct reports. Demonstrated ability to influence and lead cross-functional teams. Practical knowledge of leading and managing the execution of engineering processes, projects, and tactics across software, hardware, or test engineering. Experience testing across a range of product types including embedded/firmware, capital equipment, or connected systems. PEOPLE MANAGEMENT FUNCTION
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