Summary:
The Advanced Manufacturing Engineer (AME) is the key operations representative on New Product Development (NPD). The AME will be responsible for design and develop manufacturing processes for new products, taking into consideration problems inherent in the transfer of technology from R&D to manufacturing and providing engineering support in product transfers. The individual will be responsible for define equipment, process, material and operator specifications for manufacturing. Conducts tests and measurements throughout stages of production to determine control over applicable variables, and services, troubleshoots and solves production process problems with processes or equipment already in operation.
Essential Functions:
- Budget preparation for manufacturing line development, focusing on non-standard fixture, equipment and machine.
- Requirement specification edit, review and align with project team.
- Key Operations representative through active participation on R&D from the prototype to the new product introduction.
- Key leader in DFM/DFA assuring that production processes / equipment are taken into consideration.
- Develop manufacturing specs in support of new product introduction. Key participant in DFMEA, PFMEA processes assuring specifications are well defined and documented.
- Make the Process and Tooling Development efforts with an end goal of successfully completing Process Ranging, Characterization and Validation.
- Provide input in the design, building and implementation of new tooling in support of manufacturing transfer.
- In partnership with Finance, perform detailed cost analysis of manufacturing changes.
- Continuous improvement and cost analysis. Identify, evaluate and implement opportunities for improvement in manufacturing processes.
- Govern operations input in early supplier development and quality planning.
- Using influence management skills interface with engineering, materials control, planning, finance, document services, marketing and manufacturing in achieving common project goals.
- Advise management of developments which may affect profit, schedule and costs.
- Production Support and Trouble Shooting - Provide engineering support to manufacturing operation. Insure no negative impact on customer service and minimize downtime.
Job Qualification:
Education:
BS Engineering (Scientific or Technical discipline) or above.
MS preferred.
Experience:
BS degree in engineering with minimum 5 years applicable experience, or
MS degree in engineering with minimum 3 years applicable experience.
Preferably in regulated industries (i.e. medical, aeronautics, Automobile).
Solid experience in one or more of the following areas:
- Design and build of Assembling production processes.
- Assembling/testing equipment automation.
- Design and build of Assembly line.
- Design and build of Fixture.
- Injection molding - Mold design / mold manufacture / injection processes.
- Sheet Metal processes / die design.
- Machining.
- Die casting.
- Metallic materials.
- PCBA.
- Six Sigma / Lean production.
- DFM/DFA.
Skills/Qualifications:
- Working knowledge of GD&T, DFMEA and PFMEA, DFA/DFM principles.
- Statistical skills (basic and minimal advanced statistics), knowledge of statistical software and practices.
- Exposure to Six Sigma, DFSS, or Lean Manufacturing experience preferred.
- Experience in medical device R&D/Manufacturing desirable.
- Experience in an ISO13485 environment preferred.
- Familiarity with SFDA quality systems regulations preferred.
- Familiarity with FDA quality systems regulations preferred.
Skills/Competencies:
- Strong analytical, problem solving and negotiation skills.
- Strong interpersonal skills with ability to work with various business functions (R&D, Manufacturing, Operations, Quality, Service, etc.).
- Able to work in a cross functional team environment.
- Good oral and written communication skills, especially technical writing and presentation skills.
- Self-starter and capable of working with minimal supervision.
- Ability to multi-task across multiple projects.
- Fluency in English and Mandarin required.
职能类别: 医疗器械研发
联系方式
上班地址:上海
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