Principal Systems Engineer

Position Summary:

The Principal Systems Engineer position is a key technical leadership role at Bracco Medical Technologies and has responsibility for full-lifecycle design ownership of a single product. In this role, Principal Systems Engineer will technically lead engineering teams and integrate multi-disciplinary inputs and outputs to support the definition and development of complex software controlled electro-mechanical medical device products. As design owner, you are responsible to build device in accordance with customer, business and regulatory requirements. This involves translating stakeholder needs into product requirements to design outputs, managing technical risks of the product, and following the technology roadmap.

This Principal Systems Engineer position overlaps multiple 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 high ability to facilitate cross-functional collaboration. 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 & Responsibilities:

• Translate user and stakeholder needs into a clear and 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.
• Solve technical challenges by guiding the team through detailed trade-off analysis to develop effective, reliable solutions.
• Facilitate cross-functional technical decision making and balance technical risks, schedule and cost targets to meet product lifecycle needs.
• Lead the integration of the sub-systems and ensure that the product meets the user and system requirements with clear traceability 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 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 activities such as Failure Modes and Effects Analysis (FMEA) that identify design issues and guide the team in developing mitigations.
• Assist the team members in developing high-quality documentation, including design specifications, traceability matrices, verification test plans and reports, schedules, and change orders.
• Partner with the functional technical leaders (Architects/Principals) to develop impactful Intellectual Property that drives business growth.
• Mentor engineers in engineering activities/methodologies and domain knowledge.
• Perform work in adherence to the Bracco Medical Technologies (BMT) Quality Management System (QMS).
• 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.

Minimum

• Bachelors' degree in Engineering, or other scientific discipline, preferably electrical, mechanical, Control engineering
• 10+ years of engineering experience
• 5+ years new product development, with exposure to systems engineering roles
• Demonstrated 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 and high attention to detail
• Ability to manage multiple tasks and prioritize effectively
• Ability to work both independently and as part of a team
• Experience developing protocols, conducting system tests, and writing detailed report
• High level of initiative, enthusiasm for new technologies, and strong work ethic

Preferred:

• Graduate degree in Engineering (EE, ME or Systems Engineering) or another scientific discipline.
• 5+ years systems engineering experience
• Experience collaborating with physicians and customers during medical device product development
• Awareness and working knowledge of system-level constraints in all disciplines, including mechanical, electrical, human factors and software
• Experience gathering customer feedback and familiarity with clinical terminology
• Skilled in experimental design, data analysis, statistical methods and presenting findings

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

Compensation & Total Rewards:

Estimated Starting Salary Range: $153,000 - $168,000

*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.

Total Rewards:

• Paid Time Off, Company Holidays & Paid Family Leave - We provide PTO and Company Holidays to help you recharge, relax and do what's important to you, when it's important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
• Achieve - Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
• Live well - We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
• Evolve - Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you'll find many opportunities to grow, personally and professionally.
• Choose - You won't find "stuffy" here-whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.