Sr. 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

Reporting to Associate Director – System Engineering and working closely with a dedicated R&D team located in a different site, the candidate will 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.

The candidate must follow Corporate and Divisional Quality systems and comply with all regulatory and safety guidelines.

• Understanding 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.
• Aid the R&D team by interfacing with other core team in different time zones.

About the Role

Client is an American multinational medical technology company that manufactures and sells medical devices and also provides consulting and analytics services in certain geographies. It was one of the first companies to sell U.S.-made glass syringes. It was also a pioneer in the production of hypodermic needles and ranked #195 in the 2019 Fortune 500 list. It was also listed among the top 100 companies in Newsweek's 2009 Green Rankings. Ranking of the 500 largest American corporations based on environmental performance, policies, and reputation. Placed third in the health care sector and 83rd overall.