Lead System Designer

Job Title: Lead System Designer
Location: Wauwatosa, WI (Remote)
Duration: 6+ Months Contract (Possible Extension)
 
Job Overview:
Join the Client HealthCare Ultrasound business, specializing in ultrasound consoles, handheld devices, and IT solutions across multiple market segments. The Ultrasound Digital organization aims to innovate digital ultrasound solutions that seamlessly connect devices and software, enhancing value for customers and patients.
As a Lead System Designer (LSD), you will be integral to the program team, driving the development of AI-enabled ultrasound products within Caption and across other Client Ultrasound segments.
 
Key Responsibilities:

• Lead product development programs ensuring all design objectives meet customer and business needs, including features, quality, reliability, manufacturability, regulatory compliance, and cost.
• Drive the end-to-end product development lifecycle from requirements capture through verification, validation, and commercial release.
• Lead design teams and control processes, including requirements development, design planning, and design transfer.
• Develop and execute verification and validation plans for new product introductions (NPIs) and existing products.
• Manage requirements flow-down, system design, risk analysis, integration, testing, manufacturing, field support, and corrective/preventive actions.
• Address technical risks and ensure quality targets are met throughout the program lifecycle.
• Ensure compliance with Client Quality Manual, Quality Management System, and applicable regulatory requirements.
• Identify continuous improvement opportunities for product and process quality.
• Validate and maintain GxP relevant applications and manage change control procedures.
• Foster a quality-driven culture that supports open issue discussion and data-driven decision making.

• Bachelor’s degree in Computer Science or other STEM fields.
• Minimum 8 years of professional experience in software or medical product development, program management, or related fields; OR Master’s degree with 6 years of experience.
• 2-4 years of project leadership experience in an engineering environment.
• Proven experience in requirements development, management, and traceability to design and test procedures.
• Willingness to travel as needed.

• Master’s degree in Computer Engineering, Computer Science, or equivalent with 8-10 years industry experience.
• Experience with New Product Introduction (NPI), regulatory compliance, design history files, and related documentation.
• AI product development experience is a plus.
• Strong knowledge of Client Phase Review Discipline (PRD) and medical device regulatory processes.
• Creative problem solver with the ability to manage conflicting requirements and risks.
• Skilled at driving product/program closure and balancing multiple priorities.
• Experience working within a global matrix organization in ambiguous environments.

• Excellent interpersonal, communication, and influencing skills at all organizational levels.
• Self-motivated, proactive, and enthusiastic with minimal supervision required.