Analyze design specifications and translate the requirements into robust manufacturing procedures to achieve quality and reliability of finished products
Assesses process capabilities, prioritizes process improvement opportunities, and implements process improvements on existing manufacturing processes
Applies technical knowledge to innovate, design, and develop processes, tooling, and equipment
Defines and releases the deliverables as defined by individual design and development plans
Defines and releases installation, performance and operational qualification (IQ/PQ/OQ) protocols and reports
Product Transfers: Participate in transferring product lines across the organization
Documentation & Validation: validation protocols, technical reports. Process characterization activities and process risk management documentation
Provides design for manufacturing (DFM) input to the assembly and component specifications
Compiles and writes training materials; develops and conducts training sessions
Works collaboratively with appropriate departments/teams to develop product design and tooling processes to ensure efficient production methods
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
Estimates production times, staffing requirements, and related costs to provide information for management decisions
Estimates future manufacturing requirements and potential
Analyzes data for process investigations, productivity improvements, cost analysis, regulatory filings; documents and communicates results
Performs other related duties as assigned by management. meet production schedule
Requirements
Qualification:
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
A minimum of one (2) year at medical device or regulated industry experience
Demonstrated cross functional teamwork in technically demanding environment
Demonstrated ability to develop processes from concept to production
Strong competence with problem solving and design thinking tools. Ability to use and strong knowledge for Minitab
Highly motivated individuals that can independently drive deliverables to completion through collaboration among team members
Demonstrated ability to develop and drive innovative solutions into processes and products
Understanding of DFM, medical device design control / quality systems and the product development process (PLCP)
Excellent written and oral communication skills
Strong organizational, problem-solving, and analytical skills
Ability to manage priorities and workflow
Demonstrated ability to plan and organize projects
Good judgement with the ability to make timely and sound decisions
Creative, flexible, and innovative team player
Working knowledge of data collection, data analysis, evaluation, and scientific method
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
