We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day!
The Principal System 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 and 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 industrial engineering, 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.
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