Position Summary:
Nextern, an US based innovator in developing and manufacturing class II amp; III electro-mechanical medical devices is seeking a SeniorProcess Development Engineer for its Binh Duong, Vietnam location.
Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions.
Works cross-functionally to lead process development of complex medical devices and ensures effective transfer of designs into production. Works cross-functionally to lead process development of complex medical devices and ensures effective transfer of designs into production.
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. Provides design for manufacturing (DFM) input to the assembly and component specifications.
7. Compiles and writes training materials; develops and conducts training sessions.
8. Works collaboratively with appropriate departments/teams to develop product design and tooling processes to ensure efficient production methods.
9. Interfaces with outside vendors to determine product specifications; technical support purchase of equipment, materials, and/or parts; evaluates products to ensure they meet specifications and quality standards.
10. Estimates production times, staffing requirements, and related costs to provide information for management decisions.
11. Estimates future manufacturing requirements and potential.
12. Analyzes data for process investigations, productivity improvements, cost analysis, regulatory filings; documents and communicates results.
13. Performs other related duties as assigned by management. meet production schedule.
Requirements
1. BS in Mechanical, Electronic, Mechatronics Engineering or Biomedical Engineering and 5+ years of process development / improvement experience
2. Demonstrated cross functional teamwork in technically demanding environment
3. Demonstrated ability to develop processes from concept to production
4. Highly motivated individual that can independently drive deliverables to completion through collaboration among team members.
5. Demonstrated ability to develop and drive innovative solutions into processes and products.
6. Understanding of DFM, medical device design control / quality systems and the product development process (PLCP).
7. Excellent written and oral communication skills
8. Strong organizational, problem-solving, and analytical skills
9. Ability to manage priorities and workflow.
10. Demonstrated ability to plan and organize projects.
11. Good judgement with the ability to make timely and sound decisions.
12. Creative, flexible, and innovative team player
13. Working knowledge of data collection, data analysis, evaluation, and scientific method.
Benefits