Senior Research Engineer

Pi-Cardia, a dynamic medical device startup specializing in cardiovascular innovations, is looking for Senior Research Engineer to join our Research team. This role drives Research and V&V activities across product development, from planning and executing tests to analyzing results and maintaining DHF documentation, ensuring products meet the highest quality and regulatory standards. You’ll collaborate closely with cross-functional teams and play a key role in advancing life-changing cardiovascular technologies. Responsibilities: Create and maintain DHF documentation and ensure readiness for audits and inspections Lead end-to-end project management (timelines, resources, and deliverables) including V&V activities and risk management Coordinate cross-functional project activities with R&D, clinical and QA Develop and maintain detailed project plans, track progress, and proactively mitigate risks and delays Analyze test results, investigate anomalies, and drive corrective actions with R&D and Quality teams Support complaint handling and failure investigations Collaborate with QA/RA teams on regulatory submissions, providing V&V documentation and objective evidence

Requirements: 3+ years of experience in R&D / Research Engineering, including significant involvement in V&V in the medical device industry BSc in Engineering or Sciences (Mechanical or Biomedical preferred) Proven experience in defining and executing V&V strategies Strong understanding of the medical device development lifecycle and Design Controls (ISO 13485) Hands-on experience with DHF, design change documentation and risk management activities Knowledge of regulatory and quality requirements (FDA, EU MDR, ISO standards) Proven experience in project management, including planning, execution, and cross-functional coordination Strong organizational and time management skills with the ability to manage multiple projects simultaneously Ability to lead initiatives, drive execution, and work independently in a fast-paced environment Excellent communication and stakeholder management skills