This position is the process owner for Software Engineering and is responsible for assuring compliance with all applicable standards and procedures. This position is also responsible for supporting the process owner of the following areas: Training System, Product Analysis/Complaint/MDR/Removal/Tracking, Document Control System, Management Control System, CAPA System, Process, Test Methods System, Acceptance Activities Incoming/Finished Device, and Acceptance Activities In-Process System.
The qualified candidate will have a strong track record in managing engineering teams. In addition, they will have been well versed in product conceptualization, requirements development and software architecting, designing and developing embedded software, firmware and associated verification test systems and automation in a regulated environment. They will set the direction and approach of the department, and oversee concurrent engineering of next generation programming systems, software and implantable firmware and infrastructure necessary for developing and verifying software assets used in the company's Class III implantable medical devices and their associated peripherals, user and clinician apps, cloud data infrastructure and big data assets. The director of Software Engineering will co-develop the vision, strategy, roadmaps, and plans necessary to deliver high quality, extensible, reusable embedded software applications, firmware and test assets to the organization in support of the company’s strategic plan. This position requires the qualified candidate to manage development teams in coordination with other R&D functions, Marketing, Operations and Product Analysis groups and ensure that the customer needs of each group are satisfied. Applies broad and in-depth engineering knowledge and understands and adheres to the requirements of a regulated development and manufacturing environment to develop and set the vision, direction, approach and goals of the engineering organization. Engages in continuous engineering efforts geared toward improving efficiencies in development, process and operations. Identifies or creates best practice methods, techniques and technologies that continually improve organizational effectiveness Gathers voice of customer, roadmaps and establishes plans to better meet the needs of internal and external customers Owns process and procedures that ensure compliance and functionality. Benchmarks these against, best practice and organizational need to minimize burden and maximize benefits. Ensures that teams employ DRM (Design for Reliability and Manufacturing) tool sets when required, to include concept engineering, modeling and analysis, sensitivity studies, stress analysis, DFMA (Design for Manufacturing and Assembly) and DFT (Design for Test), and other. Coordinates, develops and maintains software technology roadmaps that support the strategic plan of the business Provides engineering oversight and assists in development activities as required. Hires, trains, motivates, retains and develops departmental staff Ensures that all regulatory and internal policies are followed Performs other duties as required.