Process Engineer

Pi-Cardia is a dynamic medical device startup specializing in cardiovascular innovations. We are dedicated to developing cutting-edge technologies that transform patient care. We are looking for a talented and hands-on Process Engineer to join our growing team and play a key role in optimizing manufacturing processes

Responsibilities:

• Develop, optimize, and validate manufacturing processes for medical devices to improve efficiency, quality, and cost-effectiveness.
• Lead root cause investigations for process deviations and implement corrective and preventive actions (CAPA).
• Identify inefficiencies, and drive process improvements.
• Troubleshoot cleanroom processes, jigs, tools, and equipment to ensure smooth operations
• Perform process validation and equipment qualification (IQ, OQ, PQ) to maintain compliance and reliability
• Design and validate manufacturing jigs and tools to improve yield and reduce failure points.
• Create and update work instructions, SOPs, and production documentation.
• Write and maintain product/production files and technical specifications.
• Ensure compliance with ISO 13485, GMP, and FDA requirements.
• Conduct statistical analysis of production data to identify trends and areas for improvement.
• Work closely with production, quality, and subcontractors to ensure smooth operations and high-quality output.
• Lead and manage engineering change orders (ECOs) to improve manufacturing efficiency.
• Collaborate with suppliers and external partners to ensure process capability and material quality.
• Problem-solving in the clean room, jigs, tools, and equipment.
• Reporting to the Engineering Manager

Qualifications:

• B.Sc. in Mechanical Engineering – Must
• 1-2 years of experience as an engineer – Must
• Experience in the medical device industry - Advantage
• Proficiency in SolidWorks
• Risk-based approach to problem-solving and decision-making.
• High ability in reading and understanding technical and mechanical drawings.
• High technical ability
• Knowledge of production technologies and experience working with production lines
• Hands-on approach with strong troubleshooting skills.
• Ability to lead processes and multitask in a fast-paced environment
• Strong analytical and problem-solving skills.
• Reading and writing at a high level in English.
• Effective communication and teamwork skills
• Attention to detail and a commitment to quality work
• Familiarity with statistical analysis tools (e.g., Minitab) - Advantage.