Principal Systems Engineer

Job Description

The Principal Systems Engineer position is a key technical leadership role at Bracco Medical Technologies (BMT) and has responsibility for the design ownership of a single product over the full lifecycle. In this role, Principal Systems Engineer will technically lead engineering teams through innovative design, development and deployment of the company's medical device products that meet customer specifications and quality standards. The Systems Engineer will integrate multi-disciplinary inputs and outputs to support the definition and development of complex software controlled electro-mechanical medical device products. As design owner of a medical device, you are responsible for ensuring that your device is built in accordance with customer, business and regulatory requirements. This is done by effectively translating stakeholder needs into 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, cybersecurity, marketing, regulatory affairs, quality assurance, and project management; a strong candidate will demonstrate a keen ability to facilitate cross-functional collaboration. The systems 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. You are responsible for ensuring alignment of product development strategy to business strategy in order to accelerate the development and commercialization of products to the market.

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 and clinical 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 the sub-systems and ensure 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 to quantitatively evaluate design concepts & solutions
• Plan, coordinate, and manage cross-functional 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 validation (summative testing)
• Engage with the test teams to ensure plans for verifications and validation activities are successful
• 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, traceability matrices, verification test plans and reports, 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
• Mentor engineers in engineering activities/methodologies and domain knowledge
• Drive systems engineering center of excellence as key discipline across the organization.
• 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

Required Skills

Minimum

• Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for U.S.-based job, if not currently employed by Bracco Medical Technologies/ACIST Medical Systems.
• Bachelors' degree in Engineering, or other scientific discipline, preferably electrical, mechanical, Control engineering
• 10+ years of engineering experience
• 5+ years new product development and exposure to systems engineering roles
• Experienced in product development activities from product inception to commercial launch
• 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 functional partners
• Strong interpersonal and communication skills
• 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, high energy, and passion about new technologies
• 3+ years ultrasound imaging experience

Preferred:

• Graduate degree in Engineering (EE, ME or Systems Engineering) or another scientific discipline.
• 10+ years systems engineering experience
• Experience working with physicians and customers in a medical device product development role
• Working knowledge of tolerance analysis, and geometric tolerance.
• 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 terminology
• Experienced in the design of experiments, data analysis, statistical methods and presentation of results
• 3+ years intravascular imaging or therapy experience
• Demonstrated experience with catheter development and manufacturing processes

Other:

• Adheres to all company policies, procedures and business ethics codes and ensures that they are communicated and implemented with the team.

• Ability to travel up to 10% of the time