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 the 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
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 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 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 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.
