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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.