Sr. PD&S Systems Engineer

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 Senior Product Development & Support (PD&S) Systems Engineer. The Senior PD&S Systems Engineer leads the delivery of expert technical support and guidance for assigned products and their applications. This position is responsible for resolving complex product-related technical challenges, supporting the development and delivery of technical training for internal teams and external partners, and contributing to initiatives that enhance product performance and customer experience. Working closely with cross-functional departments—including Engineering, QA, Product Management, and Support—the Senior PDS Systems Engineer plays a key role in influencing product design, development, and launch processes. This position requires a high level of technical acumen, problem-solving ability, and collaboration across global teams. The Senior PDS Systems Engineer’s contributions directly impact product reliability, customer satisfaction, and the overall success of the product support network

To qualify for the Senior PD&S Systems Engineer, individuals must have a Bachelor’s degree in a technical discipline such as Chemical Engineering, Biomedical Engineering, Life Sciences, or an equivalent field along with 9 years (bachelor’s degree) or 6 years (master’s degree) development experience in an IVD or medical device company. Experience with testing instruments and software in development. Experience working in a regulated environment is a plus.

Primary Responsibilities for Role:

• Champions the customer voice by collaborating with Systems Product Owners to capture, interpret, and integrate feedback into product planning, ensuring enhancements align with user needs and the company’s strategic roadmap.
• Delivers actionable, data-driven insights to Marketing, Support, and Technology teams by analyzing product performance metrics, usage patterns, and customer sentiment to inform decisions that enhance product value and competitiveness.
• Serves as a third-level escalation point for complex product issues, applying deep technical expertise to diagnose problems, recommend solutions, and guide Support teams through resolution processes that preserve customer trust.
• Leads risk management activities in accordance with FDA and ISO regulations, including hazard analysis, mitigation planning, and documentation to uphold safety and quality standards.
• Leads in-depth technical investigations in collaboration with engineering, QA, and operations teams to identify root causes, document findings, and implement corrective and preventive actions that improve product stability.
• Monitors and analyzes customer feedback from support tickets, surveys, forums, and direct interactions to identify recurring themes, quantify impact, and prioritize product improvements.
• Participates in Product Health Safety Committee (PHSC) activities, contributing to risk assessments, incident reviews, and safety audits, while supporting QA complaint investigations to ensure regulatory compliance.
• Designs and executes system performance validation studies, defining test parameters and methodologies to verify compliance with functional, reliability, and regulatory requirements.
• Independently plans, prioritizes, and manages workload, adapting to shifting priorities and delivering high-quality results under tight deadlines with minimal supervision.
• Develops and executes comprehensive testing protocols, meticulously documents results, and presents findings with clear recommendations for corrective actions or enhancements.
• Contributes to the creation, review, and validation of technical documentation such as user manuals, troubleshooting guides, and knowledge base articles to ensure clarity and accessibility.
• Collaborates with development partners, project managers, and cross-functional teams to align on milestones, resolve technical challenges, and ensure timely delivery of specifications.
• Mentors colleagues within the Product Development and Support (PDS) team by sharing best practices, offering technical coaching, and fostering a culture of continuous improvement.
• Supports verification and validation (V&V) activities by assisting in test planning, execution, and reporting to confirm alignment with design specifications and customer expectations.
• Independently plans, prioritizes, and manages workload, adapting to shifting priorities and delivering high-quality results under tight deadlines with minimal supervision.

Additional Responsibilities

• Perform occasional routine and preventative maintenance on instruments to ensure optimal performance.
• Conduct ad-hoc system tests, diagnostics, and basic troubleshooting to verify functionality.
• Identify, document, and escalate hardware issues or software anomalies to the appropriate teams.
• Provide targeted training or technical refreshers for service engineers when needed.
• Offer limited support for evaluating new firmware/software updates prior to release.

Knowledge, Skills, and Abilities

• Demonstrates a strong ability to write clearly, concisely, and effectively across both technical and non-technical audiences.
• A self-starter and self-motivated professional, that consistently takes initiative, work independently, and delivers high-quality results with minimal supervision.
• Highly detail-oriented and excels at investigating and documenting complex software defects and system behaviors.
• An analytical mindset that enables them to identify root causes, synthesize findings, and communicate actionable insights through structured, well-written reports.
• Solid understanding of scientific applications, and instrumentation, and demonstrate high proficiency in JAMA for documenting and tracking tasks, along with proficiency in ServiceMax for managing field service operations and asset workflows.
• Exceptional organizational skills and the ability to manage multiple projects simultaneously under tight deadlines
• Strong interpersonal and cross-functional collaboration skills, particularly within geographically distributed teams
• Proficiency in software validation, testing methodologies, and hands-on debugging
• High level of accountability, adaptability, and commitment to continuous improvement
• This combination of technical precision, communication excellence, and proactive problem-solving—enhanced by expertise in JAMA and ServiceMax—enables this position to be highly capable with documentation, issue resolution, and cross-functional coordination.

Education

Bachelor’s degree in a technical discipline such as Chemical Engineering, Biomedical Engineering, Life Sciences, or an equivalent field.

Experience

9 years + Bachelor's degree or 6 years + Master's degree development experience in an IVD or medical device company. Experience with testing instruments and software in development. Experience working in a regulated environment is a plus.

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 30lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Interacts with others, relates sensitive information to diverse groups.

The estimated pay scale for Senior PD&S Systems Engineer role based in San Diego, California, is $143,520 to $163,000 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and 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!

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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