Position Summary:
Nextern, an US based innovator in developing and manufacturing class II & III electro-mechanical medical devices is seeking an innovative, results-oriented
Molding-Process Senior Engineer for its Binh Duong, Vietnam location. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions.
The
Molding-Process Senior Engineer is a key member ofNextern Vietnam Production, a talented group of professionals who work together to solve problems, reach goals, and deliver products that exceed customer expectations.
This is a hands-on position in a start-up organization and an opportunity which will grow rapidly.
Job Description:
- Work with Agile to release part, BOM, drawing, spec and document related to new project: PFMEA, Process flow chart, perform the DOE of new mold, MVP/R, MP and protocols for molding inhouse plastics then come out with protocol report accordingly
- Perform OQs & PQs, documenting process parameters and run parameters
- Execution and leading process improvements through Gage R&R, Cpk and SPC
- Check the quality of molds at supplier side in each phase before sending to run in house including new molds and transfer molds from local supplier
- Support Molding to repair or modify the mold during producing or issue happened. Contact and monitor the status of mold if sending out for repairing or modification
- Work together with Molding team during running new product development including injection and Printing process
- Support troubleshooting molding issues when molding team needed on sustaining projects
- Carry out other duties as and when assigned by the management
- Continuous improvement quality and quantity, optimise the process and reduce the manpower by applying automation process
- Works with cross function team to maintain compliance with ISO 13485 and ISO 14664-1
Requirements
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
- Ethics - Consistently uses good judgment when analyzing right and wrong and performs at a level of conduct that is with corporate ethics guidelines
Qualification:
- Bachelor's degree in manufacturing, Mechanical Engineering or equivalent
- Minimum 5 years in Injection Molding Manufacturing is a must
- Having experience in medical device manufacturing, including foreign medical device manufacturing for regulated products is an advantage
- Experience in NPI projects from beginning to launch to mass production
- Proficient in using the horizontal injection press up to 300-ton, robotic part and component loading/unloading, automate part handling, vision systems, etc
- Superb English in written and communication skills
- Ability to work in a team and be an individual contributor in a fast-paced, changing workplace
- Strong troubleshooting and analytical capabilities
- Never Give Up attitude and desire to succeed, meet deadlines and achieve goals
- Working knowledge of lean manufacturing, 5S and ISO 13485 quality system methodology
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