Manufacturing Engineer IV

- Entry Level

Plano, TX

About the position

The Manufacturing Engineer is responsible for ensuring that Inogen's manufacturing operations are efficient and error-free. To achieve this goal, the Manufacturing Engineer must ensure that product designs are manufacturable, manufacturing processes are capable of achieving DPMO goals, and that the manufacturing line is adequately supported with Engineering resources. The Manufacturing Engineer will also coordinate and lead the release of new products and revisions to products from design into manufacturing.

Responsibilities

• Responsible for maintenance of product documentation, including: system BOMS/drawings, packaging BOMS/drawings, configuration management, deviations, manufacturing validations, and change control.
• Design for manufacturability review and participation.
• Manufacturing process validations including IQ/OQ/PQ.
• Manufacturing documentation generation and maintenance including manufacturing procedures, quality procedures, and equipment evaluations.
• Responsible for design control activities associated with release to manufacturing.
• Training of operators and other manufacturing personnel.
• Maintain availability for immediate response to production line issues.
• Maintain regular and punctual attendance.
• Comply with all company policies and procedures.
• Assist with any other duties as assigned.
• New product introduction, including manufacturing process development, line layouts, and validations including IQ/OQ/PQ.
• Oversight and management of manufacturing documentation and maintenance including manufacturing procedures, quality procedures, and equipment evaluations.
• Where necessary, interface with vendors to resolve quality issues.
• Improve manufacturing efficiency by analyzing cycle times, line layouts, manufacturing procedures, and identifying and implementing improvements.
• Work with test fixture engineers to develop fixtures and equipment to increase production line efficiency.
• Interface with contract manufacturers to facilitate change management, as required.
• Assist with the field service repair program, including BOM updates, procedure updates, and software revision updates, as required.
• Development and release of manufacturing related verification protocols.
• Documentation of IQ/OQ/PQ activities by completion and release of test reports.
• Project management / Lead Engineer for production transfer activities between facilities and/or contract manufacturers.
• Manufacturing Engineering representation on cross-functional projects, as assigned, including enterprise-level projects.
• Train and mentor lower-level engineers.
• Support internal and external audits for process control, validations, and equipment validations.
• Lead and manage complex manufacturing engineering projects, including developing and implementing new manufacturing processes, technologies, and automation solutions.
• Drive significant improvements in manufacturing efficiency, quality, and yield through the implementation of lean manufacturing principles and Six Sigma methodologies.
• Lead and manage the development and execution of comprehensive process validation plans (including IQ/OQ/PQ) to ensure all manufacturing processes are consistently producing high-quality products that meet regulatory requirements.
• Provide subject matter expertise on advanced manufacturing processes, equipment, and tooling. Stay current with industry trends and best practices.
• Mentor and develop lower-level engineers.
• Develop strong working relationships with other departments (R&D, Sustaining, Quality) to ensure seamless development of the manufacturing processes during product development/improvement using DFx methodologies.
• Analyze manufacturing costs and identify areas for cost reduction. Develop and implement cost-saving initiatives.
• Identify and mitigate potential risks associated with manufacturing processes and product quality.

Requirements

• Bachelor’s degree in Mechanical, Industrial, Engineering or related Scientific discipline, required.
• 1-3 years of experience in Manufacturing Engineering, required for Level I.
• 3-5 years of experience in Manufacturing Engineering, required for Level II.
• 5+ years of experience in Manufacturing Engineering, required for Level III.
• 7+ years of experience in Manufacturing Engineering, required for Level IV.
• 2+ years of medical device manufacturing experience, preferred for Level II.
• 3+ years of medical device manufacturing experience, preferred for Level III.
• 5+ years of medical device manufacturing experience, preferred for Level IV.
• Intermediate knowledge/proficiency in Microsoft Office, SolidWorks Composer and EPDM, preferred for Level I.
• Intermediate knowledge/proficiency in ISO 9001 or ISO 13485, preferred for Level I.
• Advanced knowledge/proficiency in Microsoft Office, SolidWorks Composer and EPDM, required for Level IV.
• Advanced knowledge and experience with manufacturing processes, equipment, and tooling. Proficiency in process mapping, data analysis, and project management tools, required for Level IV.

Nice-to-haves

• Medical device manufacturing experience, preferred.
• A combination of training, education, and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.