WHAT WE’RE LOOKING FOR:
The Senior Systems Engineer oversees the creation and oversight of integrated requirements for medical devices within a cross-functional team environment. Additionally, they are responsible for developing and managing the supporting programs, procedures, processes, and tools. Their primary goal is to ensure that the mechanical, electrical, and software subsystems operate seamlessly as a cohesive and dependable integrated system.
YOUR ROLE:
Leading the creation, review, and release of an integrated requirements package that incorporates risk management principles and traceability.
Defining system and subsystem architectures by applying robust systems engineering processes. This involves specifying module, component, and user interfaces.
Taking charge of Risk Management activities, including risk analysis and FMEAs.
Developing and maintaining system architecture documentation, with a focus on implementing Functional Safety.
Evaluating proposed changes to existing products and conducting root cause analyses to assess their impact on the integrated system.
Analyzing the effects of evolving regulations and standards identified by the regulatory team.
Assessing patents and determining their technical relevance to the IP landscape for new products.
Driving the Variable Cost Productivity process at the system level.
Generating and managing models and prototypes to support system and subsystem requirements analysis, design, and solution.
Allocating usage models to ensure system design life and reliability requirements are met, and participating in defining associated reliability test plans.
Collaborating with other functional team members (software, electrical, mechanical, manufacturing, service, quality, etc.) to resolve system and interface issues by evaluating overall systems performance and function.
Conducting technical reviews as part of a structured, multi-stage, gated product development process.
Contributing to the development, review, and revision of procedures that support the use of systems engineering and risk management methodologies.
YOUR BACKGROUND:
Education:
Experience:
Skills/Abilities:
Demonstrates broad technical expertise across disciplines, including electrical, mechanical, and software engineering.
Has hands-on experience in developing processes and procedures that seamlessly integrate systems engineering and risk management methodologies.
Familiar with design control processes following ISO13485 or FDA 21 CFR 820 guidelines for medical device manufacturers.
Proficient in EN60601-1 standard and skilled in risk management techniques per ISO14971.
Knowledgeable about software development standards, including IEC62304, and functional safety per IEC61508.
Understands the requirements outlined by the Medical Devices Regulation for Class II medical devices.
Competent in using and administering requirements management tools, such as JAMA Connect.
Possesses a solid grasp of embedded software technology.
Familiar with usability engineering guidelines and processes per EN62366.
Demonstrates an understanding of modeling methods for small to medium-scale systems.
Experience in medical device design is essential, and familiarity with reliability design and test methods is desirable.
Strong analytical and problem-solving skills, along with the ability to collaborate effectively across various business functions in an international environment.
Excellent oral and written communication skills, particularly in technical writing (English).
Self-motivated and capable of working with minimal supervision, adept at multitasking across multiple projects.
Six Sigma or DFSS experience is preferred.
