Description

Job Summary

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 (Specific tasks, duties, essential functions of the job)

Manufacturing Engineer I

• 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.

Manufacturing Engineer II

In addition to the items listed for Manufacturing Engineer I, a Manufacturing Engineer II may also be responsible for the following:

• 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.

Manufacturing Engineer III

In addition to the items listed for Manufacturing Engineer II, a Manufacturing Engineer III may also be responsible for the following:

• 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.

Manufacturing Engineer IV

In addition to the items listed for Manufacturing Engineer III, a Manufacturing Engineer IV may also be responsible for the following:

• 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.

Knowledge, Skills, and Abilities

• Must have strong work ethic.
• Excellent oral and written communication skills required.
• Effective conflict resolution.
• Analytical & problem-solving skills & ability to multi-task.
• Solutions-oriented problem solver.
• Excellent planning, communication, and organizational skills.
• Ability to effectively interface with different departments within the company.
• Detail oriented with attention to product quality.
• Must have knowledge or desire to implement and utilize lean manufacturing principles.
• Knowledge of FDA GMP and ISO quality systems.
• Must have a passion for product quality and excellence.
• Must have interpersonal skills appropriate for interacting with engineering and manufacturing personnel.

Qualifications (Experience and Education)

Level I

Manufacturing Engineer I

• Bachelor’s degree in Mechanical, Industrial, Engineering or related Scientific discipline, required.
• 1-3 years of experience in Manufacturing Engineering, required.
• Medical device manufacturing experience, preferred.
• Intermediate knowledge/proficiency in Microsoft Office, SolidWorks Composer and EPDM, preferred.
• Intermediate knowledge/proficiency in ISO 9001 or ISO 13485, 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.

Level II

Manufacturing Engineer II

• Bachelor’s degree in Mechanical, Industrial, Engineering or related Scientific discipline, required.
• 3-5 years of experience in Manufacturing Engineering, required.
• 2+ years of medical device manufacturing, preferred.
• Intermediate knowledge/proficiency in Microsoft Office, SolidWorks Composer and EPDM, required.
• Intermediate knowledge/proficiency in ISO 9001 or ISO 13485, required.
• A combination of training, education, and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

Level III

Manufacturing Engineer III

• Bachelor’s degree in Mechanical, Industrial, Engineering or related Scientific discipline, required.
• 5+ years of experience in Manufacturing Engineering, required.
• 3+ years of medical device manufacturing, preferred.
• Intermediate knowledge/proficiency in Microsoft Office, SolidWorks Composer and EPDM, required.
• Intermediate knowledge/proficiency in ISO 9001 or ISO 13485, required.
• A combination of training, education, and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

Level IV

Manufacturing Engineer IV

• Bachelor’s degree in Mechanical, Industrial, Engineering or related Scientific discipline, required.
• MS or PhD in Engineering or related scientific discipline, preferred.
• 7+ years of experience in Manufacturing Engineering, required.
• 5+ years of medical device manufacturing, preferred.
• 2+ years of leadership experience, preferred.
• Advanced knowledge/proficiency in Microsoft Office, SolidWorks Composer and EPDM, required.
• Advanced knowledge and experience with manufacturing processes, equipment, and tooling. Proficiency in process mapping, data analysis, and project management tools, required.
• Advanced knowledge/proficiency in ISO 9001 or ISO 13485, required.
• A combination of training, education, and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.