Principal Systems Engineer/Architect

Hologic•Newark, DE

33d•$138,000 - $230,000•Onsite

About The Position

As a Principal Systems Engineer/Architect, you will own the system architecture and implementation for advanced medical imaging and surgical products, driving innovation from concept through commercial launch. You will collaborate across engineering, regulatory, manufacturing, and quality teams-making high-level design decisions, setting technical standards, and delivering robust, reliable solutions for improved patient outcomes.

Requirements

Master's degree required (PhD preferred) in Electrical Engineering or a related technical field.
10+ years' experience (8+ with Master's, 5+ with PhD) in systems engineering, architecture, or related roles with a strong electrical engineering focus.
Deep expertise in electrical engineering design, hardware/software system interdependencies, and medical imaging technologies.
Thorough understanding of medical devices, FDA QSR, ISO 13485, and relevant risk and electrical safety standards (ISO 14971, IEC-60601-1/1-2).
Experience with software lifecycle for medical devices (IEC 62304) and Product Life Cycle Management systems.
Proven ability to lead and motivate multidisciplinary teams and manage multiple large-scale projects concurrently.
Excellent verbal, written, and presentation communication skills, including technical documentation and the ability to adapt for technical and non-technical audiences.
Strong influence management skills and ability to work cooperatively in a matrix organization.

Nice To Haves

Agile, Oracle experience beneficial.

Responsibilities

Lead system architecture design and implementation for the Surgical Division, ensuring alignment from design initiation to launch.
Define and communicate a shared technical and architectural vision across R&D and product teams.
Maintain expert knowledge of product use in clinical practice and leverage this insight to influence next-generation design and development.
Drive high-level architectural discussions, make design choices, and frame technical standards for hardware/software platforms.
Determine development processes, tools, and applications for engineering teams.
Ensure solutions under development meet intended purpose and comply with regulatory and quality standards.
Serve as a technical expert and mentor, guiding and supporting engineers across the organization.
Champion continuous improvement, ideation, and the introduction of new technologies, systems, and controls.
Lead complex design projects and help shape the product roadmap.
Collaborate with contract manufacturers, vendors, and cross-functional teams to deliver high-quality, compliant solutions.
Research emerging technologies and evaluate their integration into new products.
Guide and mentor junior engineers, promoting knowledge transfer and professional growth.
May contribute to the intellectual property position of the company through invention and patent applications.