Senior Systems Engineer - Access Vascular, Inc.

Key Responsibilities

• Lead end‑to‑end product development, owning design control and risk management throughout the lifecycle.
• Plan, execute, and document verification and validation (V&V) testing programs, including hardware, software, and system integration.
• Manage relationships with third‑party engineering, manufacturing, and testing partners to ensure timely delivery and quality.
• Ensure all development activities comply with applicable regulatory standards (FDA, ISO 13485, IEC 60601, etc.) and internal quality systems.
• Drive continuous improvement of engineering processes, tools, and documentation to meet technical, regulatory, and business objectives.

Requirements

• Bachelor’s or higher in Biomedical Engineering, Electrical Engineering, or related field with 5+ years of systems engineering experience in medical devices.
• Proven expertise in design control, risk management (ISO 14971), and V&V activities for regulated products.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and related standards.
• Demonstrated ability to lead cross‑functional teams and manage external partners.
• Excellent written and verbal communication skills, with a focus on clear documentation and regulatory submissions.