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Manufacturing Process Specialist

2 months ago


Somerset, New Jersey, United States Astrix Technology Full time
Position:
Manufacturing Process Specialist

Industry:
Engineering

Location:
Somerset County, NJ, US

Compensation:
$55-$60/hr

Overview:
As a key contributor, you will oversee and enhance the Component Qualification process.

Your responsibilities will include:
1. Leading and orchestrating process development initiatives from the creation of protocols to comprehensive data analysis.
2. Assisting in Process Validation efforts to ensure readiness for Clinical Trial Manufacturing.
3. Collaborating across departments to design, develop, and refine new manufacturing processes aimed at improving clinical trial production.
4. Supporting the development and validation of testing methodologies.
5. Implementing the Critical-to-Quality (CTQ) Cascade.
6. Spearheading Design for Manufacturing & Assembly (DFM/A) initiatives for new commercial medical devices.
7. Engaging with external equipment suppliers to acquire necessary machinery for the manufacturing processes of commercial medical devices.

Requirements:
- PhD in Chemical Engineering, Bio-engineering, or a related field.
- Proficient understanding of Medical Device Design Controls is essential.
- Experience with statistical analysis and experimental design is preferred.

Equal Opportunity Employer:
We are committed to providing equal employment opportunities to all qualified candidates without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.