Manufacturing Engineer

Company Overview:

A leading life sciences company in Dallas, Texas, focusing on innovative medical device development and commercialization, with a commitment to enhancing patient care through advanced medical technology and high-quality manufacturing.

Position Summary:

As a Manufacturing Engineer, you’ll be integral in scaling up and commercializing Class II medical devices. This role involves collaboration with production, R&D, and RA/QA teams, focusing on process development and validation .

Key Responsibilities:

• Manage Contract Manufacturing activities.
• Lead product development from clinical stage to commercialization.
• Oversee supply chain management and equipment maintenance.
• Implement cost reduction and reliability enhancement strategies.
• Conduct process improvements and validations.
• Maintain and improve technical documents.
• Design tools for manufacturing optimization.
• Assist in R&D and Regulatory Affairs documentation.

Required Qualifications:

• B.S. in Mechanical, Electrical, or Biomedical Engineering.
• Minimum 5 years in life science manufacturing.
• Proficiency in injection molding, PCBA manufacturing, and CAD (SolidWorks).
• Strong troubleshooting, supplier management, and communication skills.
• Knowledge of FDA QS regulations, ISO 13485, and Good Laboratory Practices.

Travel Requirement:

• Willing to travel 30-50%, with higher travel if not based in California.

Resumes sent directly to [email protected] will receive a response in one hour.