The Software Engineering Manager is a key leadership position in R&D Product Development to deliver innovative technology-based solutions to meet customer requirements, functionality and patient needs for Bracco Medical Technology (BMT)’s global portfolio of medical devices. As a member of the global R&D software leadership team, ensure product programs are completed on-time, team members are developed in their functional discipline, and that processes in the business are continually improved. As design owner, responsible for ensuring that solutions are built in accordance with customer, business, and regulatory requirements. This is done by effectively translating product requirements to design outputs, managing technical risks of the product, and following the technology roadmap. This role requires cross-functional collaboration with Systems engineering, Firmware, Hardware, Marketing, Regulatory Affairs, Quality Assurance, and Project management.
Primary Duties & Responsibilities:
- Provide technical direction to Software Engineering function for complex technologies in Windows and Linux environments for Medical Devices in regulated environment.
- Align the strategy and direction of the software team to the business goals and drive continuous improvement of systems, products, and processes
- Develop technology roadmaps in alignment with business strategy.
- Develop and facilitate creation of IP (Intellectual Property) and foster innovation.
- Lead Design, Development, Implementation and Verification for Device Software and Connectivity in accordance with regulatory standards.
- Functional leadership of the team, including talent development, coaching, mentoring, and career development.
- Identify the competencies required to meet the Engineering and Business objectives and develop a strategy to recruit and develop a high-performing engineering team with deep functional expertise.
- Collaborate with the Program Management team to set priorities and effectively resource programs and projects.
- Collaborate with the Principal architects and adjacent Software Engineering leaders for Design, Architecture and Platform Technologies that meets the technical, functional, performance, and operational requirements for the product.
- Lead SW Test strategy for Automation and SW Verification and Validation.
- DevOps strategy with tools and processes to optimize software engineering throughput and quality.
- Resolve technical challenges by providing guidance to the product and engineering team through rigorous trade-off analysis to create robust and effective solutions.
- Facilitate cross-functional technical decision making and optimize the balance between technical and schedule risk with the cost targets of the product lifecycle needs.
- Lead the integration of systems and devices, ensuring that the product meets the user and system requirements.
- Demonstrate the traceability of requirements through Validation and Verification.
- Lead the risk, hazard, and timeline analysis in to quantitatively evaluate design concepts & solutions
- Plan, coordinate, and manage system and cross-system design activities and interface directly with the product leadership team on project issues and status.
- Ensure key milestones are met and that solutions delivered are of the highest quality possible.
- Help the team members in developing high-quality documentation for all phases of product development, including design specifications, verification test plans, project schedules, and change orders associated with medical devices.
- Support existing products within Engineering, Manufacturing, Sourcing, Service and Supplier Quality Engineering.
- Develops products that meet requirements regulated by FDA, EU regulatory body, PMDA and other governing bodies.
- Key role in driving the culture of engineering excellence and commitment to quality.
Required Skills:
Minimum
- Bachelor’s Degree in Computer Science, Computer Engineering, Electrical Engineering, Physics, or related scientific field
- 8+ years of software engineering experience in R&D or Product Development in Medical Device or regulated industry.
- Demonstrated experience of full Software Development Life Cycle leading to Product Launches.
- Familiar with Software Design and Development in compliance with Quality Management Systems (QMS).
- 2+ years of direct or indirect people leadership experience.
- Proven ability to work cross-functionality with global teams.
- Demonstrated experience with Enterprise Architecture for complex electro-mechanical systems with connectivity.
- Track record of Technical Risk Management & Mitigation.
- Proven mentoring and coaching abilities.
- Demonstrated ability to motivate and inspire others
- Excellent communication and influencing skills with the demonstrated ability to gain buy-in for initiatives.
- Demonstrated ability to deliver results while working on multiple projects simultaneously, balancing resources, timing, and quality of outcomes.
Preferred
- Advanced degree in Computer Science, Computer Engineering, or related field.
- Experience in Medical Device domain with focus on Imaging.
- 10 years relevant industrial experience with a track record of Concept to Productization and full Product Life Cycle
- Experience in developing Medical Device Software for 5+ years, or a related field that is regulated.
- Demonstrated ability to develop Intellectual property.
- Experience with the Code and development in C# .NET, Azure DevOps, Python and related environments.
- Fluency with clinical radiology terminology.
- Knowledge of QSR, ISO/EN and Quality System Standards.
Other
- Adheres to all company policies, procedures and business ethics codes and ensures that they are communicated and implemented within the team.
- Ability to travel up to 10% of the time
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