Posted 3w ago

Process Development Engineer

@ Nextern
Ho Chi Minh City, Vietnam, Vietnam
OnsiteFull Time
Responsibilities:analyzing design, assessing processes, developing processes
Requirements Summary:Bachelor in Engineering with 3+ years in process development; medical device or regulated industry experience; DFM and design control knowledge; strong problem solving and English skills.
Technical Tools Mentioned:Minitab
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Job Description

Job Description:

1.            Analyze design specifications and translate the requirements into robust manufacturing procedures to achieve quality and reliability of finished products. 

2.            Assesses process capabilities, prioritizes process improvement opportunities, and implements process improvements on existing manufacturing processes. 

3.            Applies technical knowledge to innovate, design, and develop processes, tooling, and equipment.

4.            Defines and releases the deliverables as defined by individual design and development plans.

5.            Defines and releases installation, performance and operational qualification (IQ/PQ/OQ) protocols and reports.

6.            Product Transfers: Participate in transferring product lines across the organization.

7.            Documentation & Validation:  validation protocols, technical reports. Process characterization activities and process risk management documentation.

8.            Provides design for manufacturing (DFM) input to the assembly and component specifications.

9.            Compiles and writes training materials; develops and conducts training sessions.

10.         Works collaboratively with appropriate departments/teams to develop product design and tooling processes to ensure efficient production methods.

11.         Interfaces with outside vendors to determine product specifications; coordinates purchase of equipment, materials, and/or parts; evaluates products to ensure they meet specifications and quality standards.

12.         Estimates production times, staffing requirements, and related costs to provide information for management decisions.

13.         Estimates future manufacturing requirements and potential.

14.         Analyzes data for process investigations, productivity improvements, cost analysis, regulatory filings; documents and communicates results.

15.         Performs other related duties as assigned by management. meet production schedule.