Job Summary
The Project Engineer will report to a Business Unit Engineering Manager and possess a deep understanding of engineering principles, theories, concepts, practices, and techniques. This individual will provide manufacturing support, implement process improvement initiatives, and lead projects across various product lines.
Essential Duties and Responsibilities:
* Provide manufacturing support for multiple processes.
* Lead process improvement initiatives to reduce costs and enhance manufacturing efficiency by leveraging data analysis.
* Manage projects and oversee new product introduction projects, introducing new processes as necessary.
* Conduct process and product validations.
* Implement product, process, and material changes through validation, change control, and documentation updates.
* Familiarize yourself with diverse processes to facilitate work across numerous product lines.
* Comply with the requirements of the quality and environmental management system.
* Perform additional ad hoc duties and projects as assigned.
Qualifications and Experience Required:
* A Level 8 or equivalent degree in Engineering or a similar discipline is preferred.
* Three years' experience in a medical device manufacturing engineering role is preferred.
* Knowledge of medical device validation protocols and associated documentation is required.
* Implementation experience of validation protocols is necessary.
* Familiarity with AutoCAD and Solid Works is desirable.
* A strong background in lean and Six Sigma is essential.
* A solid process engineering foundation is required.
* New product introduction experience is valuable.
* This position requires a strong team player with the ability to work independently.
* Proficiency in due diligence and compliance in all aspects of work is essential.
* The ability to collaborate with cross-functional teams, including quality, production, and supply chain, is crucial.
* Excellent interpersonal skills are necessary.
* The capacity to plan, organize, and prioritize daily work to meet established schedules is vital.
* A good understanding of ISO 9001:2008 and ISO 13485 is required.
* Expertise in MS Office is essential.