Senior Manufacturing Engineer

Hello,

• Client: Manufacturing Industry
• Position: Medical Device Senior Manufacturing Engineer
• Location: Cambridge, MA 02139
• Duration: 05 Months Contract on W2 basis
• US Citizen OR Green Card Holder only

Max Pay Rate - $65/hr on W2 - With No Benefits

MUST HAVE :

• Education: Bachelors Degree or higher in Mechanical Engineering.
• 5+ years of experience in Medical Device Manufacturing Engineering, including at least three years in new product development, design transfer to production, and validating processes.
• Excellent modeling and drawing skills using SolidWorks, including proficiency with assemblies that contain dozens of parts.
• Experience working with contract manufacturers/vendors for capital equipment, electronics testing, and/or catheter manufacturing is strongly preferred.
• Proven track record in design transfer, process validation, and knowledge of sterilizable polymers and catheter fabrication techniques.
• Technical expertise in DFM, Six Sigma, LEAN, cGMP, and process validation.
• Proficient in SolidWorks with experience in tool and fixture design.
• Highly proficient in Microsoft Office Suite and statistical analysis software like Minitab or JMP for process monitoring and improvement

Job Description

The Sr. Manufacturing Engineer will have high collaboration between R&D, Pilot, and commercial manufacturing and contribute from Early Human Use to the commercialization of new products. The Sr. Manufacturing Engineer will also ensure that design and manufacturing processes are characterized, robust, scalable, utilize best technologies, reflect standard work, are capable and compliant with Regulatory requirements, and are validated for Design Control, Manufacturing using LEAN Six Sigma, Design for Manufacturing and Design for Cost Methodologies. The Sr. Advanced Manufacturing Engineer will act as a liaison between R&D, Supplier Development, Quality, and Operations team members assigned to the project.

Key Responsibilities (Do) :

• Developed and optimized efficient, cost-effective, and validated manufacturing processes for medical devices, focusing on capital and/or disposable devices, including assembly, lot release testing, sterilization, and packaging.
• Produce production-level assembly and part drawings for all components and sub-assemblies.
• Incorporate Design for Manufacturing (DFM), Six Sigma, and LEAN principles into product and process designs to ensure manufacturability, minimize costs, and achieve optimal production efficiency through activities like DFMA reviews and cycle time optimization.
• Proactively identify and evaluate potential contract manufacturing partners by analyzing quality, cost, delivery timelines, and regulatory compliance capabilities to recommend optimal providers.
• Lead and collaborate with contract manufacturers in selecting and developing the most efficient and reliable manufacturing processes and sites while fostering strong partnerships.

Thank you

Enterprise EQ