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.