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Job Description

Manufacturing Engineer

Direct Hire

$90,000-$120,000 + Bonus & Profit Sharing

Onsite Dallas HQ or Bay Area

(Bay Area candidates would need to relo. to Dallas in one year. Relo assistance provided)

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.