Responsibilities:

1. Process and track samples, measure and assemble parts.
2. Perform heat treatment, polishing, welding, and other treatments for products and components.
3. Promote and support product launches and related components.
4. Develop performance evaluation standards and plans, optimize product SOPs, and generate performance test reports for products and related components, along with other relevant documents.
5. Design testing and assembly fixtures and provide optimization suggestions for other product parts.
6. Create product and component drawings.
7. Complete additional tasks as assigned by the supervisor.

Qualifications:

Minimum of a college degree in mechanical engineering, polymer materials, biomedical engineering, or related fields.

Preferred experience with three types of implant products.

At least 5 years of R&D experience in the medical industry.

Responsibilities:

1. Compile R&D system-related documents.
2. Troubleshoot existing product issues.
3. Optimize product design, perform validation, and resolve technical challenges.
4. Collaborate with clinical and registration departments for product registration tasks.
5. Contribute to new project R&D.

Qualifications:

1. Bachelor's degree or higher in Mechanical-related field.
2. 1~3 years of experience in medical R&D.
3. Proficiency in medical device R&D systems and writing DHF and DMR documents.
4. Knowledge of cardiovascular or structural heart product design and manufacturing processes.
5. Strong communication skills.
6. Problem-solving ability and capacity to work independently.

Responsibilities:

1. Develop new product processes, defining methods, designing fixtures, and researching process parameters.
2. Organize and implement process validation and confirmation plans, including installation, operation, and product performance confirmation.
3. Create process flow diagrams, work instructions, flow cards, production records, and other necessary process documents.
4. Assist in transferring new product designs, including small-scale trial production and documentation.
5. Continuously improve production processes and provide technical support for production issues.
6. Ensure technical documents comply with medical system procedures and regulatory requirements.
7. Complete assigned tasks promptly as directed by leadership.

Qualifications:

1. Hold a bachelor's degree or higher in Mechanical Design or Mechanical and Electrical Engineering.
2. Preferred experience in developing processes for three types of medical devices or sterile medical products.
3. Proficiency in at least one 3D software such as AutoCAD 2D, SolidWorks, or Pro E.
4. Familiarity with ISO13485 requirements and experience in organizing or participating in process development and technology transfer for full projects is a plus.
5. Knowledge of common engineering materials, material processing, and parts processing methods is preferred. Experience with welding, shaping, polishing, and other processes is a plus.
6. Possess strong professional ethics and a collaborative team spirit