Nextern Vietnam

Nextern, an US based innovator in developing and manufacturing class II & III electro-mechanical medical devices is seeking an innovative, results-oriented Project Engineer for its Binh Duong, Vietnam location.

Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions.

The Project Engineer is a key member of the site Engineering Team and this role supports the Nextern New Product Introduction functions in Vietnam, a talented group of professionals who work together to solve problems, reach goals and deliver products that exceed customer expectations. The Project Engineer teams with the Engineering Project Lead, Business Development Manager and Engineering Management to plan and coordinate product development activities to ensure that the projects requirement and product development deliverables are accomplished within prescribed schedule and budget requirements.

Job Description:

1. Performs the project management responsibilities for engineering activities within the New Product Development (NPD) team

2. Works with engineering team leads and management to create and tracks schedules, budgets, performance targets, resource plans, prioritization and delegation of tasks, and general planning activities for engineering deliverables

3. Provides visibility to project schedule and budget issues and manages escalation and coordinates critical issue resolution with project engineering Team Lead, Business Development Manager and Engineering Management

4. Provides the project management interface to project leads as well as critical internal and external (client) stakeholders for efficient coordination, execution of critical activities and project management functions

5. Assesses and highlights risks and develops mitigation plans – active participant in the risk management ext process

6. Ensures good cross-functional communication (through effective meetings, email, and other means) to ensure coordination between Engineering functional areas and other departments.

7. Ensures successful completion of project stages gates and related activities required for the projects to comply with the company ISO 13485 / cGMP compliant design and development process

8. Ensures proper documentation is completed for each development activity, and that adequate documentation exists for the Design History File, product manufacturing and ongoing production documentation (test procedures, drawings, BOMs – Build of Material).

9. Performs post-mortem reviews on key developments and leads communication of further design improvements to projects

10. Interprets, implements, and monitors modifications to department methods, processes and policies that affect multiple work groups

11. Provides input and plans for program related expense to the engineering, quotations, budget development and forecasting

12. Carry out other duties as and when assigned by the management.

1. Requires a bachelor’s degree or higher in the Engineering field (Computer Science, Computer Engineering, Electrical Engineering preferred) or related technical degree.

2. A minimum of three (3) years total medical device development experience with at least five(5) years previous project management experience.

3. Strong competence with the various project management tools, procedures, programming languages used to accomplish the job. Minimum of six (6) years of experience is required.

4. Excellent written and verbal communication skills (ability to speak and/or read Mandarin a benefit)

5. Ability to translate, statistically analyze data, and effectively report problems through written and/or graphical formats

6. Excellent customer service skills, with an advanced understanding of internal and external customer relationship building

7. Ability to use MS Word, Excel, PowerPoint, Project tools (Celoxis and Agile knowledge is a benefit)

8. Excellent interpersonal and teamwork skills with the ability to influence, motivate, mentor, and direct team resources.

9. Ability to solve problems and implement solutions to complex problems with available resources

10. Engineering (electromechanical) experience, training, and knowledge to be able to understand and communicate effectively with the engineering teams, and to check/review their plans and progress.

11. Excellent organizational, reasoning, planning, and motivational skills.

12. Good meeting practices (proper attendance, agendas, start/stop times, minutes, actions, follow-through).

13. Self-starter; self-motivator; driven to complete projects while promoting team member success

14. Ability to adapt processes to improve inefficiencies and accelerate outcomes

15. Strong working understanding of ISO 13485 and cGMP product development requirements

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