Sr. Systems Engineer, Process Management

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

We advance science so that we all have more time with the people we love.

Roche Diagnostics acquired LumiraDx in 2024 for its unique Point of Care diagnostics platform. You will be an instrumental member of the R&D team to develop the molecular assays and next generation POC diagnostic platform. We look to innovative diagnostics which can shape the future of healthcare and change lives.

Roche is seeking a motivated Systems Engineer to join the Molecular Diagnostic group in San Diego. This individual will drive configuration management processes, ensuring effective version control and change management in compliance with medical device regulations. In addition, this engineer will collaborate with cross-functional teams, including software, hardware, regulatory, and quality teams, to ensure seamless integration of system components. This role requires expert knowledge in design and execution of experiments for the development of in vitro diagnostics. This role may require some bench-level work.  They should have a track record of independent systems engineering and the capacity to guide and mentor junior engineers, taking on senior leadership roles within the organization.

• You will lead requirements development and management, ensuring traceability across design, verification, and validation.

• You will facilitate system-level impact assessments for design changes and risk controls.You will oversee risk management activities, including risk identification, analysis, and mitigation strategies in accordance with ISO 14971.

• You will develop and maintain system engineering documentation, including design history files (DHF) and technical files.

• You will support system verification and validation activities, ensuring compliance with FDA, ISO, and IEC standards.

• You will utilize systems engineering tools for requirements tracking, risk assessment, and configuration management (e.g., Retina, DOORS, Jama, Windchill, or equivalent tools).

• You will provide technical leadership and mentorship to junior engineers, fostering best practices in systems engineering.
   

This position is based in Solana Beach, CA.
Relocation benefits are not being offered for this role.
 

Who You Are:
(Required)

• You have a Bachelor’s in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related field with 8+ years of experience or a Master’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related field with 5+ years of experience.

• You have 5+ years of experience in systems engineering within the medical device industry or a regulated environment

• You have demonstrated knowledge of ISO 13485, ISO 14971, IEC 62304, and FDA 21 CFR Part 820.

• You have demonstrated hands-on experience with requirements management tools (e.g., Retina, DOORS, Jama, or equivalent); you have demonstrated experience in risk management methodologies such as FMEA, Fault Tree Analysis, and Hazard Analysis; you have demonstrated experience with design Verification and Validation / Defect Management, Configuration Management tools and Change Control processes.
   

Preferred:

• You have experience developing and validating FDA cleared and CE Marked IVD products.

• You have experience working in a BSL-2/2+ environment.

• You have excellent problem-solving skills, analytical thinking, and attention to detail; you have strong communication skills with the ability to work in cross-functional teams.

• You have Certified Systems Engineering Professional (CSEP) or INCOSE certification.

• You have experience in cybersecurity risk management for medical devices.

• You have knowledge of Agile methodologies in medical device development.
   

WORK ENVIRONMENT
 

The essential functions of the job are usually performed in an environmentally controlled facility where the noise