The Manufacturing engineer is responsible for sustaining and continuous improvement support of production to achieve operational objectives. This person will part of a team that drives continuous improvement to achieve better product quality, availability and operational margin.
Primary QMS Responsibilities:
Validate and implement manufacturing scale-up to meet business objectives.
Develop and maintain processes, tooling, and documentation necessary to ensure the consistent manufacture of products.
Create manufacturing specifications and validate test method for in-process QC.
Create standard operating procedures and train operation for the manufacturing of products.
Perform manufacturing process improvements to achieve better product quality, availability and operational margin.
Ensure personnel are properly trained (safety and quality) on key processes and equipment.
Contribute and drive actions in support of critical on-time delivery to manufacturing schedule.
Monitor / track production process metrics and acts to ensure they meet established standards.
Ensure a high standard of product quality in accordance with ISO and the company Quality Manual.
Develop infrastructure to sustain established processes while pushing for scale-up capabilities.
Provide guidance and training to technicians to better support manufacturing.
Primary Non-QMS Responsibilities:
Drive technical projects from conceptual to qualifications to scale-up and sustaining.
Trouble-shoot and sustain manufacturing process / equipment.
Develop and mentor teams to support operational needs.
Other duties as assigned
Education and/or Experience
Bachelor’s degree in Engineering or equivalent.
2-5 years of progressive experience in a technical role (mechanical, electromechanical, and / or automation experiences a plus).
Experience with ISO-13485 high volume / single use disposable a plus.
Strong interpersonal and communication skills.
Ability to drive a technical project from start to finish within an established QMS system.
Diverse technical background with demonstrated accomplishments.
Strong computer literacy in MS Office (Work, Excel, PowerPoint, etc.) and ERP systems.