Lead and mentor software engineering teams focused on capital systems and software applications for implantable neurostimulators. Drive the full software development lifecycle, from design, development, testing, deployment, maintenance and security in compliance with FDA and international regulatory standards (IEC 62304, ISO 13485, ISO 14971). Grow and lead a global team including hiring, mentoring, career development, and performance coaching Support maintaining a strategic plan for software development that aligns with divisional goals and objectives. Foster a high-performance team culture with strong collaboration, accountability, and ownership. Partner with the product organization to develop milestone driven roadmaps for new features, and new products and service offerings. Manage software project scope, timelines, resources, and risks across multiple product lines. Lead multi-site program execution using Agile methodologies, ensuring on-time and on-budget delivery. Collaborate with systems engineering, hardware, firmware, quality, clinical and marketing teams to define software architecture and product roadmaps. Ensure software meets safety, cybersecurity, usability, and performance requirements for Class II and Class III medical devices. Foster a culture of innovation and continuous improvement in software development practices, tools and team capabilities Establish and enforce software development best practices, including design reviews, code quality standards, and robust documentation. Drive adoption of modern DevOps practices including CI/CD pipelines, automated testing, infrastructure as code, and release automation. Support design reviews, software verification, risk management, FMEA, CAPA and internal/external audits. Demonstrate effective change leadership. Demonstrate ability to succeed in fast paced environment while managing multiple projects simultaneously. Build strategic and collaborative internal and external partnerships to further team and organization objectives. Interface with external development partners and vendors as needed. Bachelor of Science degree in engineering, computer science, or software development 10+ years of experience developing software for complex systems 4+ years' experience managing engineering teams in the development of medical device software. Successful history of launching and maintaining products within the medical device industry. Proven experience in medical device software development, including capital equipment and/or applications for active implantable systems. Ability to lead a global cross functional site and build engagement. Ability to lead a multi-site team and collaborate with peers in different locations. Ability to direct and control the activities, budget, and headcount for the systems engineering organization. Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements). Familiarity with tools such as Jira, Git, Jenkins, and CI/CD pipelines. Willingness to work onsite 3+ days per week at our Arden Hills, MN site or our Marlborough, MA site. Demonstrate a keen interest in Urology, workflows, clinical features, and user experience. Experience with durable medical capital equipment or single-use devices Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Experience working with cloud-connected medical systems and mobile health ecosystems. Knowledge of patient-centric design and mobile UX in medical applications. Strong communication skills with the ability to articulate technical concepts to non-technical stakeholders. Knowledge of Agile development methodologies and familiarity with data security and patient privacy laws is a plus.
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