The Principal Systems Solution Engineer position is a key technical leadership role at BMT and will integrate inputs and outputs to support the definition and development of complex software systems involving software services that work with multiple electro-mechanical medical device products. As design owner of a product solution, you are responsible for ensuring that your solution is 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 position typically overlaps many technical and human-centered disciplines, including functional engineering, human factors, marketing, regulatory affairs, quality assurance, and project management; a strong candidate will demonstrate a keen ability to facilitate cross-functional collaboration. The engineer is a key leader in development and management of support activities such as technical planning, systems integration, verification and validation, cost and risk, life-cycle management, and effectiveness for total systems.

Primary Duties & Responsibilities:

• Ensure the logical and systematic translation of user and project needs into a comprehensive set of system and sub-system requirements in collaboration with the technical design leaders.
• Take technical ownership of the product throughout its lifecycle and provide effective technical leadership to the product and engineering teams.
• Responsible for developing a digital platform solution for Injectors and connectivity with EMR (Electronic Medical Records), including defining, maintaining, and integrating the architecture and data provided by those systems and their users
• Resolve technical challenges by providing technical 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.
• Integrate sound design principles and standards into your programs including Design for Reliability, Manufacturing, and Service.
• Identify user groups, environments, use scenarios and critical tasks for task analysis, instructions, guides, user training and system verification
• Engage with the test teams to ensure plans for verifications and validation activities are successful
• Mentor other members of the organization on hospital connectivity and interoperability
• Initiate and lead activities such as Failure Modes and Effects Analysis (FMEA) that identify design issues and lead the team in developing mitigations to address these issues.
• 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.
• Partner with the functional technical leaders (Architects/Principals) to develop significant and impactful Intellectual Property to fuel the growth of the business.
• Perform work in adherence to the Bracco Medical Technologies (BMT) Quality Management System (QMS), including development and maintenance of documentation
• Develops products that meet requirements regulated by FDA, EU regulatory body, PMDA and other governing bodies as defined by product management.
• Commit to fostering and driving an environment and work output based on continuous improvement

Qualifications (Knowledge, Skills & Abilities):

Minimum

• Bachelors’ degree in Engineering, or other scientific discipline, preferably computer, software, or control engineering
• 10 years of engineering experience
• 3-5 years new product development and exposure to systems engineering roles.
• 2 years of working with development of software products
• Demonstrated experience with Enterprise Architecture and Systems Engineering
• Technical Risk Management & Mitigation for Cloud-hosted solutions in Medical Device “connected” domain
• Knowledge of network concepts and use, including firewalls, VLANs, routing, VPNs, etc.
• Experience with hospital system connectivity, including PACS, DICOM, HL7, HIS/RIS, EMR
• Experience interfacing with Hospital IT customers, Radiologists, and imaging technicians
• Ability to grow productive, trusting, and open relationships with a wide variety of constituencies.
• Excellent communication, influencing skills and ability to gain buy-in for initiatives
• High degree of organizational skills and high attention to detail
• Ability to handle multiple tasks and prioritize effectively
• Ability to work both independently and as part of a team
• Ability to direct development of protocols and execution of system tests
• Strong initiative and passion about new technologies with high energy

Preferred:

• Graduate degree in Engineering (Software or Systems) or another scientific discipline.
• 5 years of research and development experience
• Demonstrated experience with risk management and systems engineering processes
• Experience with network authentication solutions
• Ability to develop protocols, conduct system tests and write reports
• Familiarity with Medical Device Interoperability
• Experience with IHE profiles relating to IT infrastructure and device communication
• Experience with Active Directory integration
• Understanding of IT system virtualization techniques
• Experience with Hybrid & Cloud Services, Cloud-hosted Data & Deployments
• Experience with hybrid cloud deployments
• Experience working with physicians and customers in a medical device product development role
• Experience with product concept development, customer interaction, systems engineering, verification of engineering requirements, and validation of customer needs/design requirements
• Experience with risk management and systems engineering processes
• Ability to translate needs to requirements clearly and accurately
• Awareness and working knowledge of system-level constraints in all disciplines, including mechanical, electrical, human factors and software
• Voice-of-customer experience and fluency with clinical radiology terminology.

Other:

• Adheres to all company policies, procedures and business ethics codes
• Ability to travel up to 10% of the time