Process Development Engineer

2 weeks ago


Somerset, New Jersey, United States Astrix Technology Full time
Job Summary:

As a Process Engineer at Astrix Technology, you will play a key role in supporting and leading portions of the Component Qualification process. Your responsibilities will include leading, planning, and executing process development activities from protocol generation through data analysis. You will also support Process Validation activities for Clinical Trial Manufacturing readiness and collaborate cross-functionally to design, develop, or improve and implement new manufacturing processes for clinical trial manufacturing enhancement. Additionally, you will support test method development and validation, lead DFM/A efforts for new commercial medical devices, and interact with external equipment vendors to procure equipment for commercial medical device manufacturing processes.

Key Responsibilities:

• Lead process development activities from protocol generation through data analysis

• Support Process Validation activities for Clinical Trial Manufacturing readiness

• Collaborate cross-functionally to design, develop, or improve and implement new manufacturing processes for clinical trial manufacturing enhancement

• Support test method development and validation

• Lead DFM/A efforts for new commercial medical devices

• Interact with external equipment vendors to procure equipment for commercial medical device manufacturing processes

Requirements:

• PhD in Chemical Engineering, Bio-engineering, or other related discipline

• Understanding of Medical Devices Design Controls

• Familiarity with statistical analysis and design of experiments

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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