Purpose/Objective:
- The Associate Principal Engineer (P3b) is responsible for executing the project plan tissue quality related activities for assigned new product development and sustaining while ensuring compliance to design control processes and external regulatory guidelines.
Area of Responsibilities:
- Responsible for planning of Product Validation test plan/strategy.
- Provide input to guide product development
- Ensure the quality of project planned tissue quality related activities.
- Report on product validation test conclusions.
- Reviewing product level specifications.
- Developing and executing product validation plans.
- Creating and updating Product Validation Report and maintaining integrity of the Design History File.
- Peer with Prodcut Manager to provide input for product development and analyze competitorproduct
- Be responsible for product launch training materials and providing training
- Be responsible for product field issue support
- Be responsible for optimizing product protocol and workflow
Person Specification：
Skills / Competencies
- Ability to lead lab technician team to accomplish tissue sample preparation activities of projects.
- Ability to create Validation plan based on product/project definition.
- Acts as a technical resource for colleagues with less experience.
- Excellent attention to detail as well as a big picture focus.
- Plans and Aligns - Breaks down objectives into appropriate initiatives and actions, Stages activities with relevant milestones and schedules.
- Manages Complexity - Evaluates pros and cons, risks and benefits of different solution options; Acquires data from multiple and diverse sources when solving problems.
- Balances Stakeholders - Understands internal and external stakeholder requirements, expectations, and needs.
- Manages Conflict - Works out tough agreements and settles disputes equitably.
- Acute insight on new technical and trend
- Demonstrates and applies conceptual and practical expertise in own discipline and can apply knowledge in related disciplines.
Business expertise
- Applies knowledge of best practices and analyzes which best practices should be applied in own team to achieve differientiation in the market.
- Acts as a resource for colleagues with less experience may lead to small projects with manageable risks and resource requirements.
Problem solving
- Demonstrated ability to leverage PSP to solve complex problems independently; takes a new perspective on existing solutions; exercises judgment based on limited set of data.
- Impacts quality of own work and the work of others on the team; works within guidelines and policies.
- B.S. degree in medical, histology, or related field.
- Experience in supervising technicians in histopathology lab.
- Native Chinese & Good English.
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