Some imagine the future. At SEGULA, we build it
Mission
We are currently seeking a Senior System Test Engineer to join our team in Weston, Florida. In this role, you will lead and support system-level testing of current and next-generation medical devices within our Innovation Excellence group. Your work will directly contribute to bringing new products to market that meet clinical needs and uphold the highest standards of quality and performance.
As a Senior System Test Engineer, you will apply core engineering principles across multiple disciplines to drive design verification activities. You will play a critical role in defining test strategies, execution, protocols, and ensuring that our products meet technical specifications and regulatory requirements. This role offers the opportunity to work in a dynamic, collaborative environment that values innovation, precision, and a commitment to improving patient outcomes.
Technical Responsibilities:
Apply fundamental and advanced problem-solving concepts, practices, and procedures to support root cause analysis, identify potential solutions, and evaluate them against requirements.
Ability to use statistical methods, analyze and correct complex product or fixture design issues of a moderate scope using independent judgement.
Conduct verification testing of medical devices. This can include mechanical, wear, performance and other standardized or non-standardized testing.
Under minimal supervision, develop or adapt test methods to fit product testing needs and create standard operating procedures.
Under minimal supervision, conduct research and studies to support product design.
Business Responsibilities:
Demonstrate advanced understanding of customer needs and design inputs.
Demonstrate proficiency with product’s intended use and clinical procedures.
Manage external testing projects.
Med Device Compliance:
Understand fundamental industry standards and testing strategies which align with regulatory requirements.
Follow relevant procedures: design controls, design verification, change controls, and risk management per Quality Management System.
Independently create or refine engineering documentation, such as Test Protocols, Test Reports, Test methods and Engineering Studies per local procedures.
Understand and champion laboratory best practices and compliance.
General Responsibilities:
Under minimal supervision, work with R&D, Product Development, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.
Under minimal supervision, design and evaluate components for testing. Understand test method development and contribute to test design with limited oversight.
Independently execute fixture and tool qualification per local IMTE procedure.
Learn procedures, policies, processes, systems, and relevant technology.
Demonstrate ownership and integrity of work.
Build stable relationships.
Contribute to projects as a team member.
Profil
Education Requirements:
Bachelor of Science in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or Computer Engineering.
2+ years of work experience.
Technical Skills:
Fundamental knowledge and understanding of mechanical testing (and more broadly, device testing) within a regulated environment.
Basic knowledge of analytical tools and statistical methods.
Preferred Skills / Engineering Tools:
Strong technical writing skills for reports, work instructions, protocols, procedures, and correspondence.
Must be able to generate, follow, and explain detailed instructions and design parameters.
Demonstrated knowledge and understanding of statistical concepts and analyses.
Experience in qualification or validation studies.
Experience with new product development and design controls for medical devices preferred.
Exhibit initiative, dependability, independence, motivation, and be detail-oriented with excellent analytical and problem-solving skills.