R&D Systems Engineer

T45 Labs•Santa Clara, CA

10h•Hybrid

About The Position

VahatiCor is a medical device company developing breakthrough cardiovascular technologies, including Class III catheter-based systems. We operate in an agile, collaborative environment where engineers work across disciplines to translate clinical and user needs into safe, reliable, and meaningful medical devices. The R&D Systems Engineer will support product development with primary responsibility for systems engineering activities, including requirements development and traceability, risk management, design verification and validation, design controls, and Design History File documentation. The engineer will work cross-functionally and collaboratively with R&D, Quality, Clinical, Regulatory, and Manufacturing to ensure that system requirements, risks, test evidence, and design documentation remain aligned throughout development. This role is designed for an engineer with approximately 3-5 years of medical device development experience who can bring structure and sound engineering judgment to a fast-moving R&D program while remaining close to the product and the technical work.

Requirements

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.
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.

Nice To Haves

Experience developing Class III medical devices.
Experience with cardiovascular, catheter-based, interventional, or other complex medical device systems.
Experience in an early-stage or emerging medical device company.
Familiarity with ISO 14971 and applicable FDA and international medical device design-control requirements.
Experience with requirements-management, document-control, or product-lifecycle-management tools.
Experience coordinating testing with external laboratories, suppliers, or development partners.

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 and defend DHF and project file to auditors and regulatory bodies.
Support product risk-management activities throughout the development lifecycle in accordance with applicable standards and company procedures.
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.