Sr. PD&S Systems Engineer

GRIFOLS, S.A.•San Diego, CA

3d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Experience working in a regulated environment is a plus.

Responsibilities

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.
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.