Mechanical Engineer

Qualifications

• Minimum BS/BE in Mechanical, Biomedical, Materials or Chemical Engineering or related field.
• 2+ years of experience supporting projects in product development or science/engineering research. Especially hands-on experience with design and development of high volume disposable medical devices is highly desirable.
• Strong interpersonal and communication skills.
• Demonstrated adequate mechanical design skills using CAD (SolidWorks and AutoCAD) for 3D modeling and 2D drawing.
• Understanding of testing and measurement systems.
• Understanding in protocol/procedure development for engineering studies, including mechanical and material testing.
• Careful attention to detail to ensure accurate and precise execution of work tasks and procedures.
• Adequate experience in using Microsoft office tools.
• Disciplined and well organized in documentation in a regulated environment.
• Ability to maintain composure and adapt in a dynamic, fast-paced, customer-focused work environment characterized by rapid change, minimal lead times, and multiple competing priorities.
• Ability to analyze and organize data in a clear and concise manner.

Responsibilities

• Support product development activities for medical devices and their components, including mechanical components and assembly design, preparation of documents for external customers, presentations and assistance in the development of processes.
• Follow Corporate and Divisional Quality systems and comply with all regulatory and safety guidelines.
• Understand various ISO standards for medical devices and interpret their requirements.
• Write customer facing documents, technical memo’s, reports and coordinate execution.
• Good Knowledge on Medical device design control process, product design, sterility, biocompatibility, ISO compliances, labeling & packaging standards.
• Data collection activities from SAP and other servers and cross functional teams for project inputs.
• Interfaces directly with appropriate R&D, QA, Marketing, cross functional team and plant personnel from different regions to support projects and customer inquiries.
• Develop or modify designs and 2D drawings for mechanical component and assembly design, using CAD software (SolidWorks and AutoCAD).
• Create technical documentation/presentations and maintain periodic status reports/trackers as needed to report on progress of projects on weekly basis for any risk challenges, support, directions and escalations.
• Assist the preparation of technical reports and presentations of experimental work product.
• Assist the R&D team by interfacing with other core team in different time zones.