Systems Engineer 2

Hologic•Newark, DE

1d•Onsite

About The Position

Hologic is seeking a Systems Engineer to join our Research and Development team in Newark, Delaware. In this role, you will contribute to the development of advanced medical imaging systems and electromechanical subsystems that help improve clinical outcomes. This position requires regular onsite presence in Newark, DE to collaborate closely with cross‑functional engineering teams and support hands‑on system integration, testing, and troubleshooting. You will work alongside electrical, mechanical, and software engineers, scientists, and product owners to support the design, integration, verification, and validation of medical imaging technologies.

Requirements

Bachelor’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Computer Science, or a related technical discipline.
1–2 years of experience with a technical bachelor’s degree, or 0–2 years with a master’s degree.
Understanding of systems engineering methodologies.
Experience with electromechanical design and embedded software development, ideally within the medical device field.
Experience with systems integration across electrical, mechanical, and software components.
Knowledge across multiple engineering disciplines.
Strong critical thinking, analytical, and problem‑solving skills.
Familiarity with physical and mathematical modeling tools.
Knowledge of medical device regulations and standards, including: FDA QSR, ISO 13485, ISO 14971, IEC 60601‑1 and IEC 60601‑1‑2, IEC 62304 (software lifecycle for medical devices).
Experience with Product Lifecycle Management (PLM) systems.
Strong communication, teamwork, and collaboration skills.
Experience with technical documentation and presentations.
Project management skills.

Nice To Haves

SolidWorks experience is a plus

Responsibilities

Contribute to the specification, design, component selection, system integration, verification, and validation of medical imaging systems and electromechanical subsystems.
Develop an in‑depth understanding of system architecture design and clinical use of medical imaging systems.
Propose system definitions and specifications to meet customer requirements and user needs.
Support concept development, specification, and design of new medical imaging products.
Implement new electromechanical designs and modifications within defined cost, schedule, and performance targets.
Maintain traceability between system requirements and subsystem requirements.
Maintain traceability between product requirements, identified risks, and mitigation strategies.
Perform hands‑on troubleshooting at system and subsystem levels.
Support engineering teams and system quality assurance through concept, implementation, and verification phases.
Collaborate with design engineers to define test methods and conditions.
Complete design documentation and Engineering Change Orders in accordance with Hologic procedures and best practices.
Create project schedules, track progress, and report status or issues to management and project teams.
Support design transfer to manufacturing.
Establish collaborative relationships with stakeholders across the division.
Manage multiple projects concurrently under supervision.
Continue to build technical expertise and professional development, contributing to innovative problem‑solving and product development.