Junior Project Engineer (Full-time)

Responsibilities:

• ECO Support: Manage and support all activities related to Engineering Change Orders (ECO) for software releases, hardware changes, and manufacturing processes updates, ensuring compliance with regulatory standards.
• Lead pFMEA: Conduct process Failure Mode Effect Analysis periodically to improve efficiency and conformance in the R&D department and manufacturing processes.
• Documentation: Create and maintain comprehensive project documentation for the Design History File (DHF), ensuring accuracy and completeness.
• Technical Writing: Develop clear and concise technical documents, including requirement specification documents, traceability matrices, protocols, and procedures.
• Collaboration: Work closely with cross-functional teams, including R&D, Quality, Production, and Regulatory Affairs, to ensure all documentation meets internal and external requirements.
• Compliance: Ensure all documentation and labeling comply with relevant regulatory standards and guidelines.
• Project Management: Collaborate with development teams and manage projects for new and existing company products under the design control methodology.

Requirements:

• Education: Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field).
• Experience: Previous experience in engineering projects, manufacturing processes, or technical documentation is an advantage.
• Technical Skills:
• Familiarity with Engineering Change Orders (ECO) processes.
• Knowledge of Failure Mode Effect Analysis (FMEA) methodologies.
• Experience with technical writing and documentation management.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and documentation tools.
• Soft Skills:
• Strong analytical and problem-solving abilities.
• Excellent attention to detail and organizational skills.
• Ability to work independently and as part of a cross-functional team.
• Strong written and verbal communication skills in English.
• Regulatory Knowledge: Understanding of industry standards and regulatory requirements (e.g., ISO 13485, FDA, IEC) is an advantage.
• Project Management: Strong project management skills with the ability to manage timelines, resources, and deliverables.
• Availability: Full-time availability with the ability to take on various tasks within a fast-paced, growing environment.