Manufacturing Engineer

Makro Technologies, Inc; Acton (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Makro Technologies, Inc in Acton, Massachusetts is seeking a Manufacturing Engineer to provide crucial engineering support in the production of surgical positioning products. The role requires mechanical engineering expertise to develop solutions for design and assembly challenges while ensuring regulatory compliance.

The ideal candidate will have a degree in Mechanical or Manufacturing Engineering, along with strong organizational and communication skills, and proficiency in SolidWorks. Experience in a medical product environment is preferred.

Qualifications

• 2+ years of experience working in a medical product environment preferred.
• Strong communication and written skills are essential.
• Self-motivated and enthusiastic with positive behavior.

Responsibilities

• Provide engineering support for production issues of surgical products.
• Develop solutions for assembly and design problems.
• Manage work instructions and regulatory compliance.

Skills

Mechanical engineering skills

Communication skills

Proficiency in SolidWorks or CAD software

Organizational skills

Education

Degree in Mechanical or Manufacturing Engineering

Tools

Microsoft Office (Excel, Word, PowerPoint, Outlook)

Job description

Job Description

The Manufacturing Engineer will provide engineering support for the operational issues pertaining to the production of a full line of surgical positioning products, in a Class 1 FDA regulated environment.

Use mechanical engineering skills to develop solutions for assembly and design problems and to support New Product Development, Purchasing and external vendors. Develop and maintain effective and economical manufacturing processes. Responsible for work instructions, regulatory compliance, processing engineering changes, troubleshooting problems, and supporting changes in production methods.

Responsible for total product quality, which includes resolving quality problems, certifying processes, and implementing process control.

Initiate, Prepare and Complete Engineering Change Orders.

Conduct and document engineering investigations and tests.

Revise and prepare Engineering Documentation - Drawings, 3D Models, Test Protocols, BOM's, etc.

Participate in activities related to NCMR, inspection and complaint evaluation.

Participate in Cost Reduction Activities and product redesigns.

Participate in NPD teams and Cost teams to ensure DFMA of products, review drawings, work instructions, BOM's and other engineering documents and successful transfer products to manufacturing through validation testing.

Qualifications:

2+ years of experience working in a medical product environment is preferred.

Degree in Mechanical or Manufacturing Engineering.

Innate mechanical engineering skills and hands on mechanical aptitude.

Computer experience in Windows, Microsoft Office; Excel, Word, PowerPoint and Outlook.

Strong organizational, communication and written skills.

Self-motivated/Self-driven, enthusiastic, cooperative, and positive behavior.

Proficient with SolidWorks or another CAD software program.

Additional Information

All your information will be kept confidential according to EEO guidelines.