Sr. Mechanical Engineer

About the Role

This is a 12+ month contract position located in Franklin Lakes, NJ, with a pay rate of $45-50/hr for 40 hours per week on the 1st shift. The role supports product development activities for medical devices and their components within a regulated environment.

Responsibilities

• Support product development activities for medical devices, including mechanical components and assembly design.
• Prepare documents for external customers, presentations, and assist in process development.
• Follow Corporate and Divisional Quality systems and comply with all regulatory and safety guidelines.
• Understand and interpret various ISO standards for medical devices.
• Write customer-facing documents, technical memos, and reports; coordinate execution.
• Apply knowledge of medical device design control processes, product design, sterility, biocompatibility, ISO compliance, labeling, and packaging standards.
• Collect data from SAP and other servers, and collaborate with cross-functional teams for project inputs.
• Interface directly with R&D, QA, Marketing, and plant personnel across different regions to support projects and customer inquiries.
• Develop or modify designs and 2D drawings using CAD software (SolidWorks and AutoCAD).
• Create technical documentation and presentations; maintain periodic status reports/trackers to communicate project progress, risks, and escalations.
• Assist in preparing technical reports and presentations of experimental work.
• Collaborate with R&D teams across different time zones.

Requirements

• Minimum BS/BE in Mechanical, Biomedical, Materials, or Chemical Engineering or a related field.
• 2+ years of experience supporting projects in product development or science/engineering research.
• Hands-on experience with design and development of high-volume disposable medical devices is highly desirable.
• Strong interpersonal and communication skills.
• Demonstrated mechanical design skills using CAD (SolidWorks and AutoCAD) for 3D modeling and 2D drawing.
• Understanding of testing and measurement systems.
• Experience 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 using Microsoft Office tools.
• Disciplined and well-organized documentation skills, particularly in a regulated environment.
• Ability to maintain composure and adapt in a dynamic, fast-paced work environment with rapid change, minimal lead times, and multiple competing priorities.
• Ability to analyze and organize data clearly and concisely.

Skills

• Product development for medical devices
• ISO standards and compliance
• CAD (SolidWorks, AutoCAD)
• Mechanical testing

About the Client

The client is an American multinational medical technology company that manufactures and sells medical devices, as well as provides consulting and analytics services. It was a pioneer in producing U.S.-made glass syringes and hypodermic needles, and ranked #195 in the 2019 Fortune 500 list. The company was also listed among the top 100 companies in Newsweek's 2009 Green Rankings, placing third in the health care sector and 83rd overall based on environmental performance, policies, and reputation.

Only U.S. citizens or Green Card holders will be considered for this role.

Pay

$45-50 per hour.

Schedule

40 hours per week, 1st shift.