Systems Engineer 3

Hologic•Newark, NJ

About The Position

The Lead Systems Engineer is responsible for owning and driving the system-level definition, integration, and verification of capital/hardware equipment. This role provides technical leadership across disciplines (hardware, software, firmware, mechanical, quality, manufacturing), ensures that system requirements are well-defined and traceable, and leads the team to deliver compliant, robust, and customer-focused solutions throughout the product lifecycle. This role will collaborate closely with the Quality Management System team to ensure compliance of the design history file with applicable standards and regulations.

Requirements

Bachelor’s degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Software Engineering, or related field.
7+ years of experience in systems engineering or equivalent multi-disciplinary engineering role.
Proven experience leading complex, cross-functional technical projects or products.
Hands-on experience with requirements management, system architecture, and system integration/verification.

Nice To Haves

Master’s degree in Systems Engineering or related discipline.
Experience in a regulated industry (e.g., medical devices, aerospace, automotive, industrial).
Familiarity with systems engineering standards and practices (e.g., INCOSE, V-model, MBSE, SysML, etc.).
Experience with requirements management tools (e.g., DOORS, Jama, Polarion, etc.).
Strong system-level thinking and ability to understand interactions across hardware, software, and mechanical components.
Excellent analytical, problem-solving, and troubleshooting skills.
Strong leadership, influence, and communication skills across all organizational levels.
Ability to drive alignment, make trade-off decisions, and manage ambiguity.
Organized, detail-oriented, and able to manage multiple priorities in parallel.

Responsibilities

Lead the definition of system requirements, use cases, and interfaces based on customer, business, and regulatory needs.
Develop and maintain system architecture, subsystem breakdown, and control documents.
Ensure proper requirements flow-down and traceability from system to subsystems and components.
Serve as the primary technical point of contact for system-level topics across cross-functional teams.
Provide technical support and guidance to cross-functional teams to ensure alignment with system architecture and requirements.
Lead technical reviews (requirements, design, integration, verification) and drive closure of actions and risks.
Plan and lead system integration activities, including test strategy, test plans, and test execution at system level.
Coordinate and perform system verification and validation to ensure compliance requirements and fitness for use.
Analyze test results, lead troubleshooting, and drive root cause investigations and corrective actions.
Support product sustainability, including change impact assessments.
Identify, track, and mitigate technical risks; support FMEA and other risk management activities.
Collaborate with cross-functional team to ensure design compliance, reliability, and sustainability.
Collaborate with product management and marketing to translate customer needs into system capabilities.
Contribute to project planning, effort estimation, milestones, and system-level deliverables.
Support regulatory submissions, audits, and customer interactions as the system technical owner.
Mentor junior systems and design engineers; promote best practices in systems engineering.
Champion continuous improvement of requirements management, architecture, and verification processes and tools.