Staff Systems Engineer - Instrument Systems

GRIFOLS, S.A.•San Diego, CA

44d•$161,554 - $201,943•Onsite

About The Position

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions is seeking a Staff Systems Engineer to join our R&D Instrument Systems team. This position is located in San Diego, CA and is reporting to the Senior Manager, Systems and Validation. The Staff Systems Engineer shall be an experienced, cross-functional technical leader who will be responsible for supporting all phases of complex Nucleic Acid Testing in-vitro diagnostics (IVD) system development. As a technical lead they will work as a subject matter expert to solve complex technical challenges involving hardware, software consumables and the interaction with assay development. They will lead the Systems Engineering team in subsystem definition, integration, verification and subsystem failure investigations to ensure that critical sub-systems meet their individual performance, interface and system integration goals. In order to be successful in this role, we are looking for individuals to have at least 12 years' hands on experience developing electromechanical systems/subsystems for complex medical instruments, 7 years’ experience as a Systems Engineer leading the architectural design and engineering of complex instruments, and 5 years of experience in requirements management.

Requirements

12+ years of experience developing electromechanical systems/subsystems for complex medical instruments
7+ years of experience as a Systems Engineer, leading the architectural design and systems engineering of complex instruments
5+ years of experience in requirements management
Minimum requirement: Bachelor's Degree in a technical discipline such as Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Electrical Engineering, Life Sciences or equivalent

Nice To Haves

Experienced in System Engineering techniques such as model based system engineering
Advanced knowledge of standards including IEC 60601, ISO 14971, ISO 13485 and 62366
Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
Demonstrated ability to translate high level product requirements into system and sub- system level specifications and designs System and hardware architecture definition and design
Ability to independently analyze and complex mechanical designs, circuitry and software using drawings, schematics, source code, technical education, and experience.
Excellent verbal and written communications skills. Demonstrated success in technical decision making and people management/leadership in a matrix environment.
Proven track record of developing complex products in a highly regulated environment
Requirements management using tools such as JAMA/JIRA a plus

Responsibilities

Leads Systems Engineering efforts during the subsystem integration and verification testing phases to ensure that critical sub-systems meet their individual performance, interface and system integration goals and to ensure that the fully integrated system robustly meets its performance, safety and cost requirements
Lead Systems Engineers in translating system level requirements from cross functional teams into product architecture and system level design including partitioning functionality into sub-systems, creating specifications for each sub-system, and documenting the interface requirements among the sub-system
Resolve interface issues and have the ability to document theory of operations of complex medical product designs
Design, architecture, and development of electromechanical device with embedded software
Ensure compliance to the Product Development Process, Risk Management and Quality Systems
Deliver system engineering deliverables in a timely manner to support the execution of development projects including system requirements, hardware subsystem requirements, hardware, and software dFMEAs
Utilize a growth mindset to continuously improve our Systems Engineering capabilities
Work with verification and validation engineers to define test strategies for the development of verification plans and validation plans using requirement tracing methods
Ability to mentor Systems Engineers
May be responsible for leading and/or managing other systems experts