职位概要(Job summary):
Working within a cross functional team in a collaborative and engaging manner, support the NPI programs by developing new processes and lead the transfer of the new product to mass production at the agreed quality levels.
工作职责(Responsibilities):
1. To enable new products to be successfully transferred to mass production, use lean techniques and tools to develop manufacturing processes including automated processes where applicable.
2. To ensure the final product specifications are suitable for mass production, influence product design by ensuring Design for Excellence guidelines is considered and followed.
3. Perform process verification and validation trials to determine and evaluate process repeatability & stability for new products.
4. Develop PFMEAs, Work instructions, Process flow layouts root-cause analysis investigations to ensure a high-quality throughput.
5. Manage NPI Engineers by facilitating regular 1-2-1 sessions to ensure engagement, motivation, timely resolution of issues as well as to address performance and training needs.
6. Provide visibility to NPI Team Leader of any H&S and technical issues that could inhibit mass production
7. Oversee and lead the requirements for any sample builds.
8. Drive manufacturing process efficiencies improvement opportunities ensuring robust feedback loops between departments. Communicate lessons learnt once products are in mass production.
9. Other duties and responsibilities assigned and delegated by the NPI Team Leader.
任职资格(Qualification):
1. A bachelor degree or above, at least 6 years relevant working experience of process developing experience in medical device company will be preferred.
2. Varied experience of launching new products into manufacture using a phase gated approach.
3. Good understanding in the use of lean and quality tools in a manufacturing environment.
4. Interpersonal, communication Problem solving, Analytical and lateral thinking skills.
5. Good quality mindset, FDA, ISO 13485 and medical device knowledge would be advantage.
6. Fluent English skills (written and spoken).
7. Professional, organized, passionate and self- motivated.
8. Willing to work overseas on business as needed.
职能类别：工艺/制程工程师
关键字：医疗/制药工艺开发设计医疗器械英语熟练
英语熟练