Job Overview

• Take responsibility for products quality and efficiency improvement through TEOA tools and process innovation.
• Provide prompt response to production line for any process issue to help business development. Work close with global team for mature products and process transfer from other sites to local. Standardizing process & documents.
• Process manufacturing engineer job planning and people management. Work close with each support function to achieve engineering department high performance.

Job Requirements

1. Manufacturing Process Sustaining & Improving

• Provide real time support for production for non-comfortable issues, give quick response/solution per failure analysis and experiment verification. 
• Study process flows to find opportunities for production efficiency/quality improvement through TEOA.
• Providing specialized knowledge/experience and acting as a functional expert to resolve complex manufacturing issues.

2. Process validation

• Conduct process validation for process/material/equipment changing, make sure validation plan is integrity and effective.

3. Manufacturing Process Development and Improvement

• Develop new technical innovation and improve cable & catheter assembly manufacturing process to improve quality level and efficiency to effectively support production and new business development.

4. Technical Support

• Provide technical support to tooling/fixture design and involve the key process tooling/fixture improvement to effectively support production and new business development.

5. Process Documentation Management

• Optimize and standardize manufacturing process through related documents, such as SOP (Standard Operation Process) /LA/PFMEA, etc.

6. Migration project technical lead

• Act as technical leader/expert role to work close with cross function team for migration project to ensure both products and process can be well transferred from other site to Suzhou plant.

7. Another work assigned by manager.

What your background should look like

1. Bachelor's degree in Mechanical Engineering.
2. Rich experience (10 years+) in process establishes (Have knowledge on interventional medical device process and application, such as Structural Heart and Electrophysiology related. Specially for Catheter assembly process, such as PTFE, FEB Heater shrinkage tube etc raw material properties, braider extrusion, VHS etc key process) Verification/Validation/Optimization.                                                                                  
3. Migration or transfer experience and process development are preferred.
4. Ability to communicate and interact verbally and written with other related field project team members, QE, DE and Vendors.
5. Fluent in English, communication skills and interpersonal skills, patient, communication and writing skills with a commitment to quality performance.
6. Proficiency in Microsoft Office Suite, database management.

Competencies