Lead System Designer

Job description

Job Description SummarySystems engineering is a cross-functional engineering discipline centered on an approach, mindset, and process. All activities that consider both the business and the technical needs of the customers with the goal of providing a quality product that meets the users needs. The discipline that executes a robust process of design, creation, and optimization of systems, consisting of identification and quantification of system requirements, creation of alternate system design concepts, performance of design trade studies, selection and implementation of the best designs and verification that the design is properly integrated and executed. Process that proceeds from concept to production to operation. Responsible for departmental operations planning/execution or is focused on execution of professional activities within a technical discipline. Functions with some autonomy but guided by established policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.). Job DescriptionRoles and Responsibilities Drives end-to-end medical product development, manages design controls, and ensures regulatory compliance. Lead the design team and design control process from requirements development through design transfer and commercialization. Lead verification and validation planning and execution to ensure product performance, safety, and compliance. Drive requirements decomposition, system architecture, design, integration, testing, manufacturing support, and customer support activities. Define and evolve product architecture, balancing innovation, complexity, risk, manufacturability, serviceability, cybersecurity, and quality. Influence and align large cross-functional teams across Engineering, Quality, Regulatory, Clinical, Product Management, and Manufacturing. Own technical direction and business impact for strategic platforms, products, and technologies. Mentor and coach engineers and technical leaders, fostering organizational technical excellence. Provide expert guidance in research, development, systems engineering, software, hardware, and regulatory compliance. Solve complex, high-impact technical and business challenges with limited definition and significant ambiguity. Leverage deep technical and clinical expertise to drive innovation, technology harmonization, process standardization, and quality excellence. Drive engineering best practices, technical standards, intellectual property development, and design innovation across multiple product generations. Lead end-to-end development of complex software and hardware medical products from concept, requirements, and architecture through verification, validation, regulatory clearance, commercialization, and lifecycle support. Ensure compliance with global medical device regulations and standards, including design controls, risk management, cybersecurity, and software lifecycle requirements. Lead regulatory submissions and product filings, maintaining Design History Files (DHF), technical documentation, traceability, risk management files, and supporting audits, inspections, and market approvals worldwide. Required Qualifications This role requires advanced experience in the Engineering/Technology & Systems Architecture and Design. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience). Desired Characteristics Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills. Additional InformationRelocation Assistance Provided: No