Hybrid R&D Systems Engineer - Medical Devices

T45 Labs; California; Hybrid; USD 113,000 - 128,000; Full time

Benefits offered by this job

Bonus opportunities

Equity

Company-sponsored benefits

Job summary

VahatiCor is a medical device company developing cardiovascular technologies. The R&D Systems Engineer will support product development with systems engineering responsibilities, including requirements, risk management, V&V, design controls, and DHF documentation.

The role targets engineers with approximately 3–5 years of medical device experience who can bring structure and sound judgment to a fast-moving R&D program while staying close to the product and technical work.

Qualifications

• Bachelor's degree in engineering (biomedical, mechanical, electrical, or systems)
• 3–5 years in systems engineering or related R&D in medical devices
• Experience in a medical device design-control environment
• Experience establishing and maintaining requirements and traceability
• Experience with risk management including hazard analyses and FMEA
• Experience developing/ executing design verification and validation plans, protocols, and reports
• Working knowledge of DHF requirements and disciplined documentation practices

Responsibilities

• Develop and maintain user, system, subsystem, and product requirements with cross-functional input.
• Translate clinical, user, business, and technical needs into measurable design inputs.
• Maintain bidirectional traceability among needs, inputs, risks, verification, and outputs.
• Support DHF audits and regulatory bodies with project files.
• Develop and maintain risk-management documentation throughout development.
• Facilitate cross-functional risk discussions and ensure risk controls are integrated into requirements and testing.
• Coordinate lab and system-level testing to verify and validate product requirements.
• Investigate test failures and drive root-cause analyses and CAPAs.
• Collaborate with internal and external labs/vendors to plan and execute tests efficiently.
• Contribute to design reviews, development planning, and continuous improvement of R&D systems

Skills

Systems engineering

Requirements traceability

Risk management

Design verification

Design controls

DHF documentation

Cross-functional collaboration

Technical writing

Education

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

Job description

VahatiCor is a medical device company developing cardiovascular technologies. The R&D Systems Engineer will support product development with systems engineering responsibilities, including requirements, risk management, V&V, design controls, and DHF documentation.

The role targets engineers with approximately 3–5 years of medical device experience who can bring structure and sound judgment to a fast-moving R&D program while staying close to the product and technical work.