Job Responsibility 岗位职责:

• Work with Global R&D team to familiarize with Design Inputs/Outputs and other DHF documents.

• Decomposition of system requirements into sub-systems/Modules requirements, if necessary

• Provide systems engineering support for VAVE activities on all the products manufactured in Suzhou (including but not limited to Cytometry, Centrifuge, Particle Counting, Liquid Handling product lines)

• Support the Procurement Engineering Team to initiate/execute design changes by evaluating the system impacts, risk management, design test protocol and maintaining DHF (as necessary).

• Support the Procurement Engineering Team with the interpretation and testing of Design Inputs with respect to the technical design of the product, such as characterization, verification, and validation

Qualification任职资格:

Functional Knowledge 职能知识：

• Proficient the knowledge of system engineering, at least in one of the following fields

  • dFMEA

  • Risk Management

  • Integration Test

• Possessing strong capabilities in one of the three areas: mechanical, electronics, or embedded software.

• Must possess strong verbal and written communication skills (Mandarin Chinese and English).

• Ability to work independently and in a team environment

Preferred competencies (技能加分项)

• Design experience in complex electro-mechanical systems.

• Experience with IVD and/or Life Science instrument systems.

• Experience in programming and firmware coding.

• Proficient knowledge in Automated Testing

•• Knowledge in EMC and safety standards/rules

• Familiar with ISO quality systems related to design control and product release requirements and audits.

Business Expertise业务专业知识:

• Knowledge of product safety standards (e.g. IEC 60601) would be preferred

• Knowledge of quality management standards (e.g. ISO 13485) would be preferred

Leadership领导力:

• No supervisory responsivities, but need to guidance Test engineering to draft test protocol

Problem Solving解决问题:

• Proficient in Problem solve skills to analyze complex issues.

• Proactive learning ability and willingness to acquire new knowledge.

Impact影响:

• Team players that can influence the environment for project success.

Interpersonal Skills人际交往技巧:

• Explain complex information to others in straightforward situations

Education & Experience学历与经验:

• Background in engineering and technology with experience in the RD of IVD or ME products.

• Bachelor’s degree in field with 5+ years exp. Or master’s degree in filed 3+ years exp. Or Doctoral degree in field with 0-2 years exp.