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Fortive

Senior Systems Engineer

Posted Yesterday
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In-Office
Irvine, CA, USA
Senior level
In-Office
Irvine, CA, USA
Senior level
Lead system-level architecture and requirements for medical device products. Translate customer and regulatory needs into testable requirements, support V&V, maintain design-control documentation, investigate failures, and coordinate design transfer. Provide technical guidance, collaborate with cross-functional teams, and interface with suppliers and test labs to ensure compliant, manufacturable designs.
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As a Senior Systems Engineer you will provide advanced systems engineering contributions to the design and development of medical device systems. The role supports system‑level architecture, requirements development, and lifecycle execution, ensuring customer, regulatory, and business needs are translated into robust, compliant designs. Works independently on complex assignments while collaborating closely with cross‑functional teams and senior technical leaders.

Key Responsibilities

•Contribute to the definition and implementation of system architectures for new products and product enhancements, ensuring alignment with customer needs, regulatory requirements, and business objectives.
•Translate user, customer, and business needs into clear, testable system and subsystem requirements, and support effective flow‑down to mechanical, electrical, and software teams.
•Execute system development activities across the product lifecycle, including concept development, requirements definition, design support, verification and validation, and design transfer to manufacturing.
•Develop, review, and maintain system‑level documentation such as development plans, architectures, requirements, traceability matrices, specifications, test plans, protocols, reports, and technical analyses in accordance with design control requirements.
•Provide technical guidance and informal mentorship to engineers and technicians, supporting cross‑functional problem solving and alignment.
•Support system‑level testing, failure investigations, and technical assessments, contributing to evaluations of reliability, manufacturability, serviceability, and risk.
•Interface with suppliers, external partners, and test laboratories to support design reviews, testing activities, technical issue resolution, and design transfer readiness.

Education and Experience Requirements

•Bachelor’s degree in Engineering or equivalent technical discipline, or an equivalent combination of education and experience.
•Minimum of 8 years of progressively responsible engineering experience in product and/or systems development, including exposure to system‑level design responsibilities.

Role and Competencies Requirements

•Ability to work independently on complex system development tasks with moderate oversight and guidance from senior engineers or technical leaders.
•Working knowledge of FDA, ISO, and QSR requirements applicable to medical device development and design controls.
•Experience contributing to electro‑mechanical system architectures and managing requirements through verification and validation.
•Working knowledge of root cause investigation, risk management, change management, and technical documentation.
•Effective written and verbal communication skills, with the ability to collaborate and influence cross‑functional teams and external partners.
•Working knowledge of engineering test methods, including basic statistical concepts used in development and verification.
•Ability to travel domestically and internationally up to approximately 20% as required.

About Us

Fortive Corporation Overview

Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact. 

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference. 

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone. 

At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

About the Team
About ASP 

ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.  

ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning. 

We Are an Equal Opportunity Employer
 
Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at [email protected].  

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