Job Description

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:

• Lead V&V activities, including resource planning and test protocol creation
• Analyze test results, investigate anomalies, and drive corrective actions with R&D and Quality teams
• Maintain DHF documentation and ensure readiness for audits and inspections
• Support complaint handling and failure investigations
• Collaborate with QA/RA teams on regulatory submissions, providing V&V documentation and objective evidence
• Plan and perform pre-clinical studies/research for new product indications

Requirements

• 6+ years of experience in R&D / Research Engineering with strong involvement in Verification & Validation (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, including test planning, execution, analysis, and reporting
• Strong understanding of the medical device development lifecycle and working under Design Controls (ISO 13485)
• Hands-on experience with Design History File (DHF) deliverables and managing documentation for design changes
• Knowledge of regulatory and quality requirements (FDA, EU MDR, ISO standards) and ability to apply them in V&V planning
• Excellent documentation, communication, and cross-functional collaboration skills