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.
1. 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.
2. Perform OQs & PQs, documenting process parameters and run parameters.
3. Execution and leading process improvements through Gage R&R, Cpk and SPC
4. 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.
5. 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.
6. Work together with Molding team during running new product development including injection and Printing process.
7. Support troubleshooting molding issues when molding team needed on sustaining projects.
8. Carry out other duties as and when assigned by the management.
9. Continuous improvement quality and quantity, optimise the process and reduce the manpower by applying automation process
10. Works with cross function team to maintain compliance with ISO 13485 and ISO 14664-1
Requirements
Knowledge, And Skills
1. Problem Solving - The ability to identify problems and develop and implement solutions to the issues.
2. Decision Making - The ability to make "value added" decisions in a timely manner at all levels of the organization.
3. Strategic Thinker - The ability to creatively develop effective responses and plans to people, problems, or issues.
4.Communication Skills - The ability to effectively communicate ideas, arguments, solutions, and work through conflict resolution at all levels of organizations both internally and externally.
5. Negotiation - The ability to plan for, implement and communicate the "elements of negotiations" that create value for Nextern, while maintaining supplier relationships.
6. Ethics - Consistently uses good judgment when analyzing right and wrong and performs at a level of conduct that is with corporate ethics guidelines
Qualification:
1. Bachelor’s degree in manufacturing, Mechanical Engineering or equivalent.
2. Minimum 5 years in Injection Molding Manufacturing is a must.
3. Having experience in medical device manufacturing, including foreign medical device manufacturing for regulated products is an advantage
4. Experience in NPI projects from beginning to launch to mass production.
5. Proficient in using the horizontal injection press up to 300-ton, robotic part and component loading/unloading, automate part handling, vision systems, etc.
6. Superb English in written and communication skills
7. Ability to work in a team and be an individual contributor in a fast-paced, changing workplace.
8. Strong troubleshooting and analytical capabilities
9. “Never Give Up” attitude and desire to succeed, meet deadlines and achieve goals.
10. Working knowledge of lean manufacturing, 5S and ISO 13485 quality system methodology
Benefits
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.
At Nextern, we inspire with passion, impact with significance, and act with integrity.
