Performs the project management responsibilities for all cross-functional activities within the New Product Development (NPD) team and sustaining projects.
Works with engineering, quality and production 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
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 Vietnam Leadership Management
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
Assesses and highlights risks and develops mitigation plans - active participant in the risk management ext process
Ensures good cross-functional communication (through effective meetings, email, and other means) to ensure coordination between Engineering functional areas and other departments.
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
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).
Performs post-mortem reviews on key developments and leads communication of further design improvements to projects
Interprets, implements, and monitors modifications to department methods, processes and policies that affect multiple work groups
Provides input and plans for program related expenses to the engineering, quotations, budget development and forecasting
Carry out other duties as and when assigned by the management.
Knowledge, And Skills
Problem Solving - The ability to identify problems and develop and implement solutions to the issues.
Decision Making - The ability to make "value added" decisions in a timely manner at all levels of the organization.
Strategic Thinker - The ability to creatively develop effective responses and plans to people, problems, or issues.
Communication Skills - The ability to effectively communicate ideas, arguments, solutions, and work through conflict resolution at all levels of organizations both internally and externally.
Negotiation - The ability to plan for, implement and communicate the "elements of negotiations" that create value for Nextern, while maintaining supplier relationships
Qualification:
Requires a bachelor's degree or higher in the Engineering field (Computer Science, Computer Engineering,
Electrical Engineering preferred) or related technical degree. PMP certification is a plus.
A minimum of six (6) years total medical device development or regulated industry experience with at least five (5) years previous project management experience.
Strong competence with the various project management tools, procedures, programming languages used to accomplish the job.
Excellent written and verbal communication skills (ability to speak and/or read Mandarin a benefit)
Excellent English written and verbal communication skills
Ability to translate, statistically analyze data, and effectively report problems through written and/or graphical formats
Excellent customer service skills, with an advanced understanding of internal and external customer relationship building
Ability to use MS Word, Excel, PowerPoint, Project tools (Smartsheet, celoxis and PLM systems knowledge is a benefit)
Excellent interpersonal and teamwork skills with the ability to influence, motivate, mentor, and direct team resources.
Ability to solve problems and implement solutions to complex problems with available resources
Engineering (electromechanical and medical device) experience, training, and knowledge to be able to understand and communicate effectively with the engineering teams, and to check/review their plans and progress.
Excellent organizational, reasoning, planning, and motivational skills.
Good meeting practices (proper attendance, agendas, start/stop times, minutes, actions, follow-through).
Self-starter; self-motivator; driven to complete projects while promoting team member success
Ability to adapt processes to improve inefficiencies and accelerate outcomes
Strong working understanding of ISO 13485 and cGMP product development requirements
PHYSICAL DEMANDS AND WORK ENVIORNMENT
Occasionally required to stand
Occasionally required to walk
Continually required to sit
Continually required to utilize hand and finger dexterity
Occasionally required to climb, balance, bend, stoop, kneel or crawl
Continually required to talk or hear
While performing the duties, the noise level in the work environment is usually moderate
The employee must occasionally lift and /or move more than 40 pounds
Specific vision abilities required by this job include: Close vision
