Qualifications

• 5-8 years of experience in software applications engineering, particularly in medical devices or pharmaceuticals.
• Strong understanding of FDA regulations, ISO standards, and GMP guidelines.
• Proven track record of successful design and development projects from concept to commercialization.
• Excellent collaboration skills to work with cross-functional teams.
• Experience in performing risk assessments and validation activities.

Responsibilities

• Design and develop software systems for medical devices and pharmaceutical production.
• Collaborate with multiple departments to ensure compliance with regulatory standards.
• Conduct risk assessments to identify potential issues in product development.
• Support validation and verification processes for software applications.
• Troubleshoot and resolve manufacturing issues related to software applications.
• Contribute to design transfer documentation for smooth product roll-out.

Benefits

• Opportunity to work on cutting-edge technology in the medical and pharmaceutical fields.
• Collaboration with a diverse team of experts across various disciplines.
• Ongoing professional development and training opportunities.
• Impact on enhancing patient safety and product quality.
• Exposure to regulatory compliance processes and standards.