Systems Engineer II

The Systems Engineer II will contribute to the design and development of novel medical device systems at Access Vascular Inc., with a focus on catheter tip location and vascular access technologies. The role includes supporting product development through system integration, requirements management, verification and validation, and cross-functional collaboration. The ideal candidate will have hands-on experience working with mechanical, electrical, hardware, and software components in a regulated medical device environment.

Key responsibilities may include, but are not limited to:

• Design & Development Support: Collaborate in the development and integration of systems combining mechanical, electrical, hardware, and software components, ensuring performance and usability meet clinical needs.
• System Requirements: Contribute to the development, documentation, and traceability of system and sub-system requirements.
• Risk Management: Participate in risk analysis and hazard assessments.
• Testing & Verification: Assist in the design and execution of verification and validation protocols. Conduct testing, analyze results, and document findings in alignment with design control requirements. Produce test reports, and release reports in to QMS via DCO process.
• Cross-Functional Collaboration: Work closely with internal and external teams in marketing, mechanical, electrical, hardware, software, catheter engineering, clinical, and quality to ensure cohesive system development.
• Engineering Documentation: Support the preparation and maintenance of Design History File with detailed engineering documentation including system specifications, risk management files, and test protocols/reports.
• Regulatory Support: Assist the regulatory team with FDA Class II 510(k) submission.
• Process & Compliance: Follow and contribute to established development processes aligned with FDA regulations, ISO 13485, ISO 14971, ISO 62304, IEC 60601, and company procedures.

• Education: B.S. in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field. M.S. a plus.
• Experience: 3–6 years of experience in medical device product development; experience with 510(k) or PMA submissions preferred.
• Technical Proficiency:
• Familiarity with system integration of mechanical, hardware, electrical, and software subsystems.
• Hands-on experience with benchtop testing, troubleshooting, and prototype evaluation.
• Working knowledge of software development for medical devices and cybersecurity is preferred
• Regulatory & Standards Knowledge: Working knowledge of FDA QSR, ISO 13485, and ISO 14971.
• Software & Tools:
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Project).
• Exposure to requirements management and risk analysis tools (e.g., DOORS, Jira, or similar).
• Communication & Teamwork: Strong communication and organizational skills. Comfortable working independently or within cross-functional teams.

• Familiarity with catheter technologies or tip location systems.
• Experience with signal processing, sensor integration, or embedded systems.
• Exposure to design for manufacturability and reliability (DFM/DFR) practices.
• Familiarity with software development (e.g. C, C++, Java)
• Working knowledge of cybersecurity for medical devices