Staff Systems Engineer

Advanced Sterilization Products; Irvine (CA); On-site; USD 158,000 - 263,000; Full time

Job summary

Advanced Sterilization Products, a Fortive company, seeks a Staff Systems Engineer to lead system-level design for complex medical devices from concept through transfer to manufacturing. You will translate customer and regulatory requirements into executable designs and guide cross-functional teams.

The role emphasizes collaboration, risk management, and maintaining rigorous design controls while mentoring engineers and coordinating with suppliers and test labs.

Qualifications

• 10+ years of progressively responsible engineering experience in product and/or systems development.
• Experience with system-level design, integration, or verification activities.
• Working knowledge of FDA, ISO, and QSR requirements applicable to medical device development and design controls.
• Proficiency in root cause investigation, risk management, change management, and technical documentation.

Responsibilities

• Contribute to the definition, development, and refinement of system architectures for new products and significant product enhancements.
• Translate user, customer, and business needs into clear, testable system and subsystem requirements.
• Support system development activities across the product lifecycle, including concept development, requirements definition, design, verification and validation, and design transfer to manufacturing.
• Develop and maintain system-level documentation, including development plans, architectures, requirements, traceability matrices, specifications, test plans, and reports.
• Provide technical guidance and informal mentorship to engineers and technicians across disciplines.

Skills

Systems engineering

Requirements management

Verification & validation

Design controls

Cross-functional collaboration

Root cause analysis

Education

Bachelor’s degree in Engineering

Job description

The Staff Systems Engineer provides advanced technical leadership and hands‑on systems engineering support for the design and development of complex medical device systems. This role contributes to system‑level architecture definition, translates customer and regulatory requirements into executable designs, and supports system development activities from concept through design transfer. The position operates with moderate autonomy, influencing technical decisions through strong systems expertise and effective cross‑functional collaboration.Key ResponsibilitiesContribute to the definition, development, and refinement of system architectures for new products and significant 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 of requirements to mechanical, electrical, and software teams.Support and execute system development activities across the product lifecycle, including concept development, requirements definition, design, verification and validation, and design transfer to manufacturing.Develop, review, and maintain system‑level documentation, including development plans, architectures, requirements, traceability matrices, specifications, test plans, protocols, reports, and technical analyses, in accordance with design control processes.Provide technical guidance and informal mentorship to engineers and technicians, coordinating across disciplines and contributing to technical direction under the guidance of senior technical or project leadership.Support system‑level testing, failure investigations, and technical assessments, evaluating reliability, manufacturability, serviceability, and risk throughout developmentAct as a technical contributor and interface to suppliers, external partners, and test laboratories, supporting design reviews, testing execution, issue resolution, and design transfer readiness.Education and ExperienceBachelor’s degree in Engineering or a related technical discipline, or an equivalent combination of education and experience.Minimum 10+ years of progressively responsible engineering experience in product and/or systems development, including exposure to system‑level design, integration, or verification activities.Role and Competencies RequirementsDemonstrated ability to contribute effectively to complex, multi‑disciplinary system development efforts with defined objectives and moderate oversight.Working knowledge of FDA, ISO, and QSR requirements applicable to medical device development and design controls.Experience supporting electro‑mechanical system architectures and managing requirements through verification and validation.Proficiency in root cause investigation, risk management, change management, and technical documentation.Effective written and verbal communication skills, with the ability to collaborate with cross‑functional teams, suppliers, and external partners.Working knowledge of engineering test methods and basic project management principles, including statistical concepts used in development and verification.Ability to travel domestically and internationally up to approximately 20% as required.Fortive Corporation OverviewFortive's essential technology makes the world safer and more productive. We accelerate transformation in high-impact fields like workplace safety, build environments, and healthcare.We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in healthcare sterilization, industrial safety, predictive maintenance, and other mission-critical solutions. 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 advanced technologies that help providers focus on exceptional patient care.We are a diverse team 10,000 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 Advanced Sterilization ProductsASP 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 [e-mail] or EquityThis position is also eligible for bonus as part of the total compensation package.Pay RangeThe salary range for this position (in local currency) is 157,780 - 263,465ASP 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 [e-mail] salary range for this position (in local currency) is 157,780 - 263,465This position is also eligible for bonus as part of the total compensation package.