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.
Requirements
Qualification:
1. Requires a bachelor’s degree in the Engineering field (Mechanical Engineering, electrical, electromechanical, biomedical Engineering) or related and 3+ years of process development / improvement experience.
2. A minimum of one (2) year at medical device or regulated industry experience.
3. Demonstrated cross functional teamwork in technically demanding environment
4. Demonstrated ability to develop processes from concept to production.
5. Strong competence with problem solving and design thinking tools. Ability to use and strong knowledge for Minitab.
6. Highly motivated individuals that can independently drive deliverables to completion through collaboration among team members.
7. Demonstrated ability to develop and drive innovative solutions into processes and products.
8. Understanding of DFM, medical device design control / quality systems and the product development process (PLCP).
9. Excellent written and oral communication skills
10. Strong organizational, problem-solving, and analytical skills
11. Ability to manage priorities and workflow
12. Demonstrated ability to plan and organize projects
13. Good judgement with the ability to make timely and sound decisions
14. Creative, flexible, and innovative team player
15. Working knowledge of data collection, data analysis, evaluation, and scientific method.
16. Good English written and verbal communication skills.
Benefits
- Benefits Competitive salary
- Professional and Friendly Working Environment, chance to attend employee's training and development programs
- Premium healthcare Insurance (In Vietnam) & Business travel insurance Health, social & unemployment insurance (following Government regulation)
- Company trip, New Year party, Team building
- Occasion-based offerings: Birthday, New year, Mid-Autumn
Skills Required
- Bachelor's degree in Engineering
- 3+ years of process development/improvement experience
- 2 years of experience in medical device or regulated industry
- Strong knowledge of Minitab
- Understanding of DFM and medical device design control
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
