Grifols

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.

Primary Responsibilities for Role

• 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

Additional Responsibilities

• May be responsible for leading and/or managing other systems experts

Knowledge, Skills, and Abilities

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

Experience

• 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

Equivalency

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Occupational Demands

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

Pay Scale

The estimated pay scale for the Staff Systems Engineer role based in San Diego, California, is $161,554.30 to $201,943.45 per year. Additionally, the position is eligible to participate in up to 15% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

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Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

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Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg

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