Systems Engineer II
Systems Engineer II
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Salary Not Disclosed
1 Vacancy
Job Description
Job Description
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.
Duties and Responsibilities
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.
Qualifications and Experience
- Education: B.S. in Electrical Engineering Mechanical Engineering Biomedical Engineering or a related technical field. M.S. a plus.
- Experience: 36 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.
Preferred Skills
- 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
About Access Vascular
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .
Employment Type
Full Time
