Job Description

The Senior Systems Engineer will lead new product development efforts at Access Vascular Inc., with primary ownership of design control and risk management processes throughout the product lifecycle. This role is responsible for driving all V&V testing programs, including managing external third-party engineering, manufacturing, and testing partners, ensuring all development activities are conducted in compliance with applicable regulatory standards. This individual ensures that best engineering practices and efficient processes are employed to meet technical, regulatory, and business objectives.

Duties and Responsibilities

• • Design & Development: Lead the design and development of a medical device with electrical, software, and mechanical features, in compliance with QMSR. Define and maintain system architecture across mechanical, electrical, embedded software and firmware subsystems, ensuring coherent interfaces and traceability.
  • Project Management: Drive Verification and Validation planning and execution, including test protocol authorship, IQ/OQ/PQ activities, and clinical readiness assessments.
  • Technical Leadership: Provide technical leadership and direction to internal and third-party engineers, technicians, and consultants involved in device design and development.
  • Documentation & Compliance: Contribute to the Risk Management File in accordance with ISO 14971, including hazard identification, risk estimation, risk evaluation, risk controls, and residual risk assessment across the full product lifecycle. Generate and maintain design input specifications, design output documentation, requirements traceability matrices, and risk management documentation. Support the compilation and submission of regulatory filings (510(k), PMA) and patents.
  • Verification & Validation: Lead system-level design verification and validation activities, including development of V&V plans, protocols, test scripts, and summary reports. Conduct and manage test method validation.
  • Design Improvements: Analyze data for conformance to design specifications and recommend and implement design improvements to product platforms.
  • Standards Compliance & Regulatory Testing: Plan and manage testing to applicable standards, including IEC series, AAMI EC standards and ASTM standards as applicable to the device. Maintain awareness of evolving regulatory guidance (FDA) and standards updates and assess impact on the device design and test program.

Skills/Competencies

• Educational Background: B.S. in engineering discipline (e.g., Electrical, Mechanical, Biomedical, Software). M.S. preferred.
• Experience: 7+ years’ experience in medical device product development, including FDA regulated devices covered by 510(k) or PMA. Demonstrated hands-on experience leading design control and risk management programs required. Prior startup or early-stage company experience — comfort with ambiguity, rapid iteration, and wearing multiple hats.
• Leadership: Proven effective motivational leadership skills, with experience in building and managing teams to deliver product designs on schedule. Experienced in managing third-party engineering and manufacturing partners, including supplier qualification and technical oversight.
• Technical Proficiency: Proficient in the design of systems with mechanical, electrical, and software elements. Working knowledge of ECG signal characteristics, including waveform morphology, common artifact types, signal conditioning, and clinical measurement standards (AAMI EC57, IEC 60601-2-25). Capable of creative problem solving, quick comprehension, and rigorous skeptical analysis. Proficient with requirements management and traceability tools. Experience with V&V testing and test method validation required. Experience with ECG, cardiac monitoring, or electrophysiology devices strongly preferred. Experience with mechanical, electrical, and software systems required; experience with catheter technologies preferred.
• Communication: Excellent verbal and written communication skills to support working within a team and demonstrated ability to communicate complex technical concepts to a diverse audience.
• Regulatory Knowledge: Thorough knowledge of applicable standards and regulations, including QMSR, ISO 14971, IEC 60601-1, IEC 60601-1-2 and other collateral standards, IEC 60601-2-25 (ECG equipment), AAMI EC11/EC57, ISO 10993. Familiarity with FDA guidance documents on design controls, software (IEC 62304), and risk management.
• Software Skills: Proficient with Microsoft Office Software products, including MS Project,; requirements management tools (e.g., DOORS, Jama, Polarion), collaboration tools (Jira), familiarity with embedded C/C++ or firmware development, Python.