Senior Systems Engineer, R&D

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 Hologics 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.

Key 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).

Required Qualifications and Experience

• Bachelors degree in Systems Engineering Biomedical Engineering or a related engineering discipline is required. Advanced degree in a relevant discipline is preferred.
• Minimum of 8 years of relevant engineering experience or Masters degree with 6 years/PhD with 4 years preferably in medical devices diagnostics or other regulated industries.
• Prior experience with in vitro diagnostics (IVD) systems or instruments is preferred.
• 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 ISOCFR 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.

The annualized base salary range for this role is $120100 to $188000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience skillset knowledge geography education business needs and market demand.

Why 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.

If you have the right skills and experience apply today!

#LI-RF1 #LI-MidLevel

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

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