1st Shift 8:00 AM - 5:00 PM Monday, Tuesday, Wednesday, Thursday, Friday
This position independently leads complex activities and tasks in support of manufacturing operations. Activities and tasks are conducted on materials, products, processes, and equipment.
• Demonstrate a primary commitment to patient safety, product quality and compliance with the Quality Manual and its governing regulations.
• Independently lead complex activities to design, document, and improve manufacturing processes and operations that control the safety and efficacy of components or finished devices.
• Independently lead qualification, verification, and validation activities for the production of components or finished medical devices.
• Analyze, troubleshoot, and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices.
• Participate in design control efforts related to risk analysis (FMEA) & design reviews.
• Source component and service suppliers; assess supplier capability and effectiveness.
• Train, and provide work direction to operators and technicians.
• Design and coordinate complex engineering tests and experiments. Analyze data, draw conclusions, and summarize test results. Communicate results to the technical community.
• Influence decisions around alternative engineering processes, products and equipment.
• Ability to work well with others in a team setting.
• Ability to effectively communicate with all levels of management.
• Ability to conduct complex statistical, geometric and mathematical calculations.
• Ability to adopt & defend technical positions in an open and collaborative environment.
• Demonstrated ability to effectively write and review technical documents & investigative reports.
• Demonstrated project/task management skills.
• Ability to conduct responsibilities substantially free from routine supervision.
• Ability to work efficiently on common personal computer hardware and software