Systems Engineer - Instrument Systems

Staff Systems Engineer - Instrument Systems –
Grifols Shared Services North America, Inc.

Location:

San Diego, CA. This role reports to the Senior Manager, Systems and Validation.

Pay Range

$ / yr – $ / yr.

Grifols Diagnostic Solutions is seeking a Staff Systems Engineer to join our R&D Instrument Systems team. The Engineer will be responsible for supporting all phases of complex Nucleic Acid Testing (NAT) IVD system development, acting as a technical lead and subject matter expert in hardware, software, consumables, and assay integration.

• Lead systems engineering during subsystem integration and verification testing to ensure that critical subsystems meet performance, interface, and system integration goals and that the fully integrated system meets safety, performance, and cost requirements.
• Translate system‑level requirements into product architecture and system‑level design, partition functionality into subsystems, create specifications for each subsystem, and document interface requirements.
• Resolve interface issues and document theory of operation for complex medical product designs.
• Design, architect, and develop electromechanical devices with embedded software.
• Ensure compliance with the Product Development Process, Risk Management, and Quality Systems.
• Deliver system engineering deliverables on time, including system requirements, hardware subsystem specifications, and software/ hardware dFMEAs.
• Use a growth mindset to continuously improve engineering capabilities.
• Collaborate with verification and validation engineers to define test strategies and develop verification and validation plans using requirement tracing methods.
• Mentor other Systems Engineers.

• May lead or manage other systems experts.

• Experience in model‑based systems engineering.
• Advanced knowledge of IEC 60601, ISO 14971, ISO 13485, and ISO 62366.
• Solid understanding of theories/practices used in disciplines outside the primary area of expertise.
• Ability to translate high‑level product requirements into system and subsystem specifications and designs.
• Independent analysis of complex mechanical designs, circuitry, and software using drawings, schematics, source code, and technical education.
• Excellent verbal and written communication skills.
• Proven track record of developing complex products in a highly regulated environment.
• Experience with requirements management tools such as JAMA/JIRA.

• 12+ years of experience developing electromechanical systems/subsystems for complex medical instruments.
• 7+ years as a Systems Engineer leading architectural design and systems engineering of complex instruments.
• 5+ years in requirements management.

Directly related experience, combined education and experience, or competencies may be considered in place of the stated requirements.

Office environment, 6‑8 hours per day at a desk. Repetitive hand movements, light to moderate lifting (maximum 25 lb). Ability to communicate complex information effectively.

Annual salary $ – $ plus up to 15 % bonus pool. Benefits include medical, dental, vision, PTO, up to 5 % 401(k) match, and tuition reimbursement.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices, national origin, pregnancy, protected veteran status, or disability. Grifols complies with applicable laws including the California Fair Chance Act and Los Angeles County Fair Chance Ordinance.