Senior Systems Engineer, R&D

Hologic•San Diego, CA

4d•Onsite

About The Position

Discover a Technology career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day. The Senior Systems Engineer is a senior individual contributor responsible for leading complex system-level design, integration, and verification activities for Hologic’s diagnostic products and platforms. Operating under limited supervision, this role drives cross-functional technical execution from concept through commercialization, ensuring that hardware, software, reagents, and consumables work together as a robust, compliant, and user-centric in vitro diagnostic (IVD) system. The Systems Engineer IV mentors junior engineers and is a key contributor to design control activities. This is a fully onsite role in San Diego, CA.

Requirements

Bachelor’s degree in Systems Engineering, Biomedical Engineering or a related engineering discipline is required.
Minimum of 8 years of relevant engineering experience or Master’s degree with 6 years/PhD with 4 years, preferably in medical devices, diagnostics, or other regulated industries.
Demonstrated experience leading system-level development, integration, and verification of complex electromechanical or mechatronic systems.
Strong understanding of systems engineering principles, including: Requirements development and management. System architecture and interface definition. Risk management and reliability engineering. Verification and validation strategies.
Familiarity with regulated product development, preferably under ISO 13485, 21 CFR 820, and IVD-specific standards (e.g., IEC 61010, IEC 61326).
Proficiency with systems engineering tools (e.g., requirements management tools such as DOORS, Jama, or equivalent) and data analysis software.
Solid foundation in one or more core engineering domains (e.g., mechanical systems, fluidics, thermal, controls, optics, or software-driven instrumentation).
Strong analytical and problem-solving skills with a demonstrated ability to manage ambiguity and complexity.
Effective communication skills, both written and verbal, with the ability to clearly present technical information to diverse audiences.
Proven ability to work effectively in cross-functional teams and to influence without direct authority.
Strong organizational skills with the ability to manage multiple tasks and priorities in a fast-paced environment.

Nice To Haves

Advanced degree in a relevant discipline is preferred.
Prior experience with in vitro diagnostics (IVD) systems or instruments is preferred.

Responsibilities

Participates in cross-functional core teams to develop IVD systems and ensure the product design will meet customer requirements as well as applicable standards and regulations.
Develop and manage systems level product requirements.
Plan and lead multi-disciplinary integration activities for instrument, software, and assay components.
Troubleshoot complex system issues, identify root causes, and drive closure of technical problems across disciplines.
Develop and execute system-level verification plans, protocols, and test methods in accordance with design control procedures.
Utilize risk analysis methods in decision making.
Assist in sustaining engineering activities, including investigations of field issues, CAPAs, and product improvements.
Ensure compliance with design control processes (requirements management, traceability, verification/validation, change control).
Serve as a subject matter resource for systems engineering methods, tools, and best practices.
Mentor and provide technical guidance to junior engineers and peers.
Lead technical design reviews and present system-level design and test results to internal stakeholders.
Support preparation of technical content for regulatory submissions (e.g., design descriptions, performance data, risk assessments).