ESSENTIAL FUNCTIONS:
The responsibilities include but are not limited to work within a broader product development team to:
· Participate in ideation, conceptualization, design, verification and validation, manufacturing support to product end of life for Medical Products or Life Science devices and other relevant experiences that includes categories such as Consumer, commercial, industrial and military products.
· Participate in design reviews to surface issues and derive optimal robust solutions that satisfy customers' business, product, and quality needs.
· Collaborate with the same discipline, cross-functional team members, and customer's R&D engineers.
· Communicate design concepts, technical trade-offs, and engineering solutions.
· Perform fundamental mechanical engineering functional tasks including:
· Manage sub-assembly/component projects to meet defined objectives, including targeted cost, schedule and budget.
· Define/refine requirements, specifications, and architecture, and design mechanical components, subsystems, and systems.
· Oversee the on-time manufacture and delivery of components and sub-assemblies.
· Develop functional & reliability test plans to verify that the product is able to meet all quality requirements for components, subsystems, and integrated systems.
· Perform functional and reliability tests of components, subsystems, and systems, troubleshooting and resolving issues.
· Create the necessary documentation for the components, subsystems, and systems, including reference specifications, design documents, drawings, process instructions and all other documentations needed to meet the respective regulatory requirements (ISO 13485 & FDA 21 CFR 820) for the Design History File (DHF).
· Maintain engineering responsibility of the components, subsystems, and systems through the product life cycle, and create product change orders as necessary.
Perform senior engineering roles including:
· Develop mechanical architecture of new products.
· Provide technical leadership to other engineers
· Ability to conduct experimentation & generate reports to customers.
· Possess good communication skills in English, both written & oral as this position will entail engaging external customers.