Staff Systems Engineer - Instrument Systems jobs in United States
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Grifols · 1 month ago

Staff Systems Engineer - Instrument Systems

Grifols is a global healthcare company that has been working to improve health and well-being since 1909. They are seeking a Staff Systems Engineer to lead the R&D Instrument Systems team, focusing on complex Nucleic Acid Testing in-vitro diagnostics system development and integration. The role involves leading engineering efforts, resolving technical challenges, and ensuring compliance with product development processes.

BiotechnologyHealth CareManufacturing
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H1B Sponsor Likelynote

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

Qualification

Systems EngineeringElectromechanical SystemsRequirements ManagementModel Based System EngineeringIEC 60601 StandardsISO 14971 StandardsISO 13485 StandardsISO 62366 StandardsTechnical Decision MakingPeople ManagementCommunicationMentoring Skills

Required

Minimum requirement: Bachelor's Degree in a technical discipline such as Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Electrical Engineering, Life Sciences or equivalent
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
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

Preferred

Requirements management using tools such as JAMA/JIRA a plus

Benefits

Medical
Dental
Vision
PTO
Up to 5% 401(K) match
Tuition reimbursement

Company

Grifols is a global healthcare company.

H1B Sponsorship

Grifols has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (1)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$2.51B
Key Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B

Leadership Team

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Camille Alpi
Chief Human Resources Officer
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Víctor Deu
Director of Planning & Control Department
Company data provided by crunchbase