R&D Systems Engineer – Medical Devices

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

Job summary

VahatiCor is seeking an R&D Systems Engineer to join our hybrid Santa Clara-based team. You will lead systems engineering activities, develop requirements, manage risk, and contribute to DHF documentation across R&D, Quality, Regulatory, and Manufacturing.

You will translate clinical and user needs into measurable inputs, maintain traceability, support design controls, and collaborate to ensure tests and documentation meet regulatory standards in a fast-moving medical device environment.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical, Electrical, or Systems Engineering.
• 3-5 years of systems engineering or closely related R&D experience within medical device product development.
• Hands-on experience in a medical device design-control environment.
• Experience developing and 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.
• Strong technical writing, analytical, organizational, and problem-solving skills.
• Ability to work effectively across technical disciplines and functions in a fast-paced, evolving development environment.

Responsibilities

• Develop, document, and maintain user, system, subsystem, and product requirements in collaboration with 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.
• Support and defend DHF and project file to auditors and regulatory bodies.
• Develop and maintain design verification and validation strategies, plans, protocols, test methods, and reports.
• Coordinate and participate in laboratory, bench, and system-level testing to demonstrate that the product meets approved requirements.
• Own failure investigations, Health Hazard Evaluations (HHEs), Nonconformance Reports (NCRs), and CAPAs.
• Balance documentation rigor with the speed and hands-on participation required in a fast-moving medical device environment.

Skills

Systems engineering

Requirements management

Risk management

Design controls

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Biomedical Engineering / Mechanical Engineering / Electrical Engineering / Systems Engineering

Job description

VahatiCor is seeking an R&D Systems Engineer to join our hybrid Santa Clara-based team. You will lead systems engineering activities, develop requirements, manage risk, and contribute to DHF documentation across R&D, Quality, Regulatory, and Manufacturing.

You will translate clinical and user needs into measurable inputs, maintain traceability, support design controls, and collaborate to ensure tests and documentation meet regulatory standards in a fast-moving medical device environment.