Systems Engineer 3

Hologic, Inc.; Newark, Marlborough (DE, MA); On-site; USD 98,000 - 153,000; Full time

Benefits offered by this job

Annual bonus

Training & development

Job summary

Hologic, Inc. seeks a Lead Systems Engineer to own system-level definition, integration and verification of capital hardware.

You will lead cross-disciplinary teams across hardware, software, firmware, mechanical and quality to ensure well-defined, traceable requirements and compliant, robust solutions throughout the product lifecycle. You will drive system architecture, requirements flow-down, verification planning, and risk management, collaborating with regulatory and manufacturing functions

Qualifications

• Bachelor’s degree in a related engineering field and 7+ years in systems engineering or similar.
• Hands-on with requirements management, system architecture, and integration/verification.
• Proven experience leading cross-functional technical projects or products.
• Knowledge of design history file, regulatory expectations, and risk management.

Responsibilities

• Own system definition, requirements, use cases, and interfaces across domains.
• Lead architecture development and ensure traceability from system to components.
• Drive system integration, test strategy, plans, and verification activities.
• Lead risk management and FMEA activities with cross-functional teams.
• Collaborate with product, regulatory, and manufacturing to deliver compliant solutions.
• Mentor engineers and promote best practices in systems engineering.

Skills

System thinking

Analytical skills

Leadership & communication

Decision making

Organizational skills

Education

Bachelor’s degree

Master’s degree

Tools

DOORS

Jama

Polarion

Job description

Position Summary

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.

Key Responsibilities

• System Definition & Architecture
  • 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.
• Technical Leadership
  • 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.

• Integration & Verification
  • 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.
• Lifecycle & Risk Management
  • 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.
• Stakeholder & Project Support
  • 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.
• Mentoring & Continuous Improvement
  • Mentor junior systems and design engineers; promote best practices in systems engineering.
  • Champion continuous improvement of requirements management, architecture, and verification processes and tools.

Required Qualifications

• 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.

Preferred Qualifications

• 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.).

Key Skills and Competencies

• 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.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and an annual bonus scheme, one of our talent partners can discuss this in more detail with you.

The annualized base salary range for this role is $97,600 - $152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.