Supports complex planning of detailed product development objectives. Provides technical support on manufacturing testing issues that affect production. Creates software project updates to eliminate testing issues and defects found in manufacturing testing. Completes process and design issues documentation for future reference and problem resolution.
In this role, the individual will support test projects, apply industry best practices, and self-manage to proactively drive and deliver tester updates and transfers to meet critical business milestones.
This individual must apply electrical and mechanical engineering principles towards test fixture design and software engineering principles towards tester software design while incorporating FDA regulatory and site quality system requirements into the process activities. The ability to synthesize multiple sources of business and technical requirements to produce an optimized solution is key.
A successful candidate will be able to effectively engage, influence, set priorities and support the expectations of the cross-functional teams that provide inputs to the tester development process or are stakeholders of the finished product.
Create documentation packages and track the procurement of material
20% travel time to US and Global Mfg sites
Ability to interface with cross functional groups to update testing systems for medical device manufacturing
Ability to create and execute project schedules
Ability and experience on project schedule reporting to management
Ability to communicate functional specifications and testing requirements with hardware software developers
Ability to read testing schematic diagrams
Understanding of manufacturing process validation
Experience in design and manufacturing in a new product development environment.
Experience in developing and implementing design of test and assembly fixtures.
Interface experience with R&D, Manufacturing, Supply Chain, Quality and Regulatory functions.
Excellent written, oral, planning and interpersonal communication skills with the ability to discuss or explain design features or issues with all level engineers, designers and drafters.
Can work independently in a fast paced new product development environment.
Highly self-motivated, self-directed, team orientated, and exceptionally attentive to detail.
Proactively resolves issues in a timely manner so that they do not affect project timelines.
Electrical engineering or Electromechanical engineering degree or equivalent
2 - 5 years of professional engineering experience