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
  
  

• 4+ 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