This position independently leads complex activities and tasks in support of manufacturing operations. Activities and tasks are conducted on materials, products, processes, and equipment. Receives minimal direction and review of deliverables.
Demonstrate a primary commitment to patient safety, product quality and compliance with the company, Quality Manual and its governing regulations.
Conduct activities, tasks, and documentation according to the quality system requirements
Design, document, and improve manufacturing processes and operations that control the safety and efficacy of finished devices.
Conduct qualification, verification, and validation activities for the production of medical devices.
Specify and procure tooling and fixtures.
Support supplier capability assessments
Train, develop, and/or provide work direction to operators and technicians.
Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.
Design and coordinate engineering tests and experiments. Analyze data, draw conclusions, and summarize test results.
A four-year technical degree from an accredited institution or acceptable equivalent (engineering preferred)
Three years of engineering experience with one year experience in a manufacturing engineering role
Ability to work well witah others in a team setting
Ability to communicate effectively across the organization and external associates
Ability to conduct complex statistical, geometric, and mathematical calculations
Ability to conduct responsibilities substantially free from routine supervision
Ability to read and understand engineering drawings
Ability to work efficiently on common office computer hardware and software