R&D Systems Engineer — Hybrid Medical Devices

T45 Labs; Santa Clara (CA); Hybrid; USD 113,000 - 128,000; Full time

Job summary

VahatiCor in Santa Clara, California, is seeking an R&D Systems Engineer to support system engineering activities across requirements, risk management, and verification/validation for our Class III catheter-based cardiovascular devices. The role collaborates with R&D, Quality, Regulatory, Clinical, and Manufacturing to keep design documentation aligned with project goals.

Ideal candidates have 3–5 years in medical device development, hands-on experience with design controls, and strong writing

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Systems Engineering, or a related engineering discipline.
• 3-5 years of systems engineering or closely related R&D experience within medical device product development.
• Hands-on experience working within a medical device design-control environment.
• Experience developing or managing product requirements and requirements traceability.
• Experience supporting medical device risk management, including hazard analysis and FMEA activities.
• Experience developing and executing design verification and/or validation plans, protocols, and reports.
• Working knowledge of Design History File requirements and disciplined engineering documentation practices.

Responsibilities

• Develop, document, and maintain user, system, subsystem, and product requirements in collaboration with technical and cross-functional team members.
• Translate clinical, user, business, and technical needs into clear, measurable, and testable design inputs.
• Maintain bidirectional traceability among user needs, design inputs, risk controls, verification and validation activities, and design outputs.
• Identify gaps, conflicts, and dependencies within documents and ensure compliance with necessary standards and regulatory guidance documents.
• Support product risk‑management activities throughout the development lifecycle.
• Develop and maintain risk‑management documentation, including hazard analyses, design/use/process FMEAs, risk evaluations, risk‑control measures, and risk traceability.
• Facilitate cross‑functional risk discussions and ensure identified risk controls are incorporated into requirements, design outputs, and verification activities.
• Evaluate new information, design changes, and test results for potential impact on the risk management file.
• Develop and maintain design verification and validation strategies, plans, protocols, test methods, acceptance criteria, and reports.
• Coordinate and participate in laboratory, bench, and system‑level testing to demonstrate that the product meets approved requirements and intended use needs.
• Review test data for completeness and technical integrity and clearly document conclusions.
• Investigate test failures, anomalies, and unexpected results; drive appropriate follow‑up, root‑cause evaluation, and documentation.
• Collaborate with internal teams and external laboratories or vendors to plan and execute testing efficiently.
• Support design‑control activities from development planning through design transfer.
• Help maintain an inspection‑ready DHF in accordance with company procedures and applicable regulatory requirements.
• Communicate technical risks, dependencies, decisions, and testing status clearly to project stakeholders.
• Contribute to technical problem‑solving, design reviews, development planning, and continuous improvement of R&D systems and practices.
• Own failure investigations, Health Hazard Evaluations (HHEs), Nonconformance Reports (NCRs), and Corrective and Preventive Actions (CAPAs).
• Balance documentation rigor with the speed and hands‑on participation required in an early‑stage medical device company.

Skills

Requirements management

Traceability

Risk management

Systems engineering

Cross-functional collaboration

Technical writing

Education

Biomedical/Systems Engineering degree

Job description

VahatiCor in Santa Clara, California, is seeking an R&D Systems Engineer to support system engineering activities across requirements, risk management, and verification/validation for our Class III catheter-based cardiovascular devices. The role collaborates with R&D, Quality, Regulatory, Clinical, and Manufacturing to keep design documentation aligned with project goals.

Ideal candidates have 3–5 years in medical device development, hands-on experience with design controls, and strong writing