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.
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.
