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.

• 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

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, HIS/RIS, EMR

• Experience interfacing with Hospital IT customers, Radiologists, and imaging technicians

• Experience with network authentication solutions

• Demonstrated experience with risk management and systems engineering processes

• Demonstrated ability to clearly and accurately translate needs and requirements

• 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 develop protocols, conduct system tests and write reports

• 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

• 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 and 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