Startup line Engineer

Join our Research and Development team as a 3D Printed Medical Device Startup Line Engineer with a focus on manufacturability of medical devices. In this role, you will collaborate with a small team to produce custom medical devices using cutting-edge 3D printing technology. You will be instrumental in developing, manufacturing, and transferring new products and processes at our pre-pilot 3D Medical Device R&D line.

Working alongside cross-functional engineering teams, you will leverage your expertise to creatively solve problems and develop innovative solutions. This position is crucial for sustaining, improving, and transferring Align Technology's pilot line manufacturing programs, driving the success of new product initiatives.

* Develop, maintain, report, and improve pilot line R&D and production KPIs (Safety, Quality, Output, Yield, Availability, etc.).

* Maintain and enhance existing manufacturing control systems and dashboards.

* Implement and refine Lean manufacturing tools, including 5S, constraint identification, and waste elimination.

* Collaborate with cross-functional design and process teams to meet production and R&D goals.

* Create detailed manufacturing work instructions, operating procedures, and documentation in accordance with Align's quality policy, with a focus on manufacturability and design transfer.

* Train stakeholders on new initiatives.

* Participate in or lead root cause analysis and CAPA activities from internal and external audits.

* Partner with cross-functional engineering groups to evaluate, implement, and improve processes and equipment applications.

* Generate CAD drawings for continuous improvement (e.g., layouts, workstations, fixtures, shadow boards).

* Address issues with urgency and meticulous attention to detail.

* Continuously improve existing systems and assist in evaluating and implementing new software tools.

* Optimize processes and implement improvements for transferability and scalability.

* Assist in defining and transferring metrics and processes to high-volume international plants.

* Thrive in a fast-paced environment and meet critical deadlines.