Principal Systems Engineer LinkedIn Twitter Email Message Share Why Join Bracco Medical Technologies? At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesaving decisions. We create medical devices that give healthcare providers the insights they need to confidently and safely diagnose patients. Our unique line of products includes Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR), Cardiovascular Imaging contrast delivery (CVi), and CT and MRI contrast delivery systems. Position Description The Principal Systems Engineer role at Bracco Medical Technologies is a key technical leadership position responsible for overseeing the design of a product throughout its entire lifecycle. In this role, the engineer brings together multi-disciplinary inputs and outputs to guide the development of complex software-controlled electro-mechanical medical devices. As the design owner, you must ensure that the product meets customer expectations, business needs, and regulatory standards. This involves translating stakeholder needs into product requirements and design outputs, managing technical risks, and following the company's technology plans. The Principal Systems Engineering role touches many areas, including industrial engineering, functional engineering, human factors, cybersecurity, marketing, regulatory compliance, quality assurance, and project management. A successful candidate will be skilled at promoting teamwork across different departments. The engineer also plays a leading role in activities like technical planning, systems integration, verification and validation, managing risks and costs, and overseeing the product's lifecycle to ensure it performs effectively. Primary Duties and Responsibilities: Translate user and project needs into a clear set of system and sub-system requirements in collaboration with technical design leaders and defined system architecture. Take full technical ownership of the product throughout its lifecycle and provide strong leadership to product and engineering teams. Solve technical challenges by guiding the team through detailed trade-off analysis to develop effective, reliable solutions. Facilitate cross-functional decision-making and balance technical risks, schedules, and cost targets to meet lifecycle needs. Oversee the integration of sub-systems and ensure the product meets user and system requirements, with clear traceability through validation and verification. Lead risk, hazard, and timeline analysis to evaluate design concepts and solutions quantitatively. Plan, coordinate, and manage cross-functional design activities while reporting project issues and progress directly to the product leadership team. Incorporate design principles such as Design for Reliability, Manufacturing, and Service into all development efforts. Identify user groups, environments, scenarios, and critical tasks to support task analysis, instructions, training, and system validation. Collaborate with test teams to ensure successful planning and execution of verification and validation activities. Initiate and lead Failure Modes and Effects Analysis (FMEA) to identify design issues and guide the team in developing solutions. Assist team members in creating high-quality documentation, including design specifications, test plans, schedules, and change orders. Work with technical leaders (Architects/Principals) to develop impactful Intellectual Property that drives business growth. Follow the BMT Quality Management System and maintain documentation accordingly. Ensure products meet applicable regulatory requirements from bodies such as the FDA, EU, and PMDA. Promote a culture of continuous improvement, driving both process and product development forward. Qualifications (Knowledge, Skills & Abilities): Required Bachelor's degree in Engineering or a related scientific field, preferably in Electrical or Mechanical Engineering 10+ years of engineering experience 5+ years of xperience in new product development, with exposure to systems engineering roles Proven experience with risk management and systems engineering processes Ability to accurately translate needs and requirements into clear technical outcomes Skilled at building productive, trustworthy, and collaborative relationships across different teams and stakeholders Excellent interpersonal and communication skills Strong organizational skills with great attention to detail Ability to manage multiple tasks and set priorities effectively Capable of working independently and within a team environment Experience developing protocols, conducting system tests, and writing detailed reports High level of initiative, enthusiasm for new technologies, and strong work ethic *Preferred Graduate degree in Engineering (Electrical, Mechanical, or Systems Engineering) or a related scientific field 5+ years of experience in systems engineering Experience collaborating with physicians and customers during medical device product development Understanding of system-level constraints across multiple fields, including mechanical, electrical, software, and human factors Experience gathering customer feedback and familiarity with clinical radiology terminology Skilled in experimental design, data analysis, statistical methods, and presenting findings Experience with radiology systems and procedures 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 Job Location 7905 Fuller Road, Eden Prairie, Minnesota Tracking Code 1335-432 ACIST Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.