Accessvascular
Sr. Systems Engineer
Billerica, MA · Senior
Sponsorship not specified$120k-$155kDetected 26 days ago
C++Product ManagementProject ManagementJiraEmbedded SystemsSystems EngineeringFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingMicrosoft Office
About the role
- This individual ensures that best engineering practices and efficient processes are employed to meet technical, regulatory, and business objectives.
Responsibilities
- 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.
- Define and maintain system architecture across mechanical, electrical, embedded software and firmware subsystems, ensuring coherent interfaces and traceability.
- Drive Verification and Validation planning and execution, including test protocol authorship, IQ/OQ/PQ activities, and clinical readiness assessments.
- Provide technical leadership and direction to internal and third-party engineers, technicians, and consultants involved in device design and development.
- 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.
- 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.
- Analyze data for conformance to design specifications and recommend and implement design improvements to product platforms.
Requirements
- Demonstrated hands-on experience leading design control and risk management programs required.
- 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.
Nice to have
- B.S. in engineering discipline (e.g., Electrical, Mechanical, Biomedical, Software).
- 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.
Skills
- Compensation Commensurate With Experience
- $120,000 - $155,000 USD
- About Access Vascular
- Skills/Competencies
- Skills/Competencies - Educational Background: B.S. in engineering discipline (e.g., Electrical, Mechanical, Biomedical, Software).
Compensation
- Commensurate With Experience
- 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..
Benefits
- Lead the design and development of a medical device with electrical, software, and mechanical features, in compliance with QMSR.
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