The Manufacturing Engineering Manager is responsible for ensuring that Inogen’s manufacturing operations at an assigned location are efficient and error free. To achieve this goal, the Manufacturing Engineering Manager must work to continuously improve the manufacturing capabilities and results at the assigned location. This position must additionally ensure manufacturing processes are capable of achieving FPY goals, and that the manufacturing line is adequately supported with Engineering resources. The Manufacturing Engineering Manager will also coordinate and lead the release of revisions to products into manufacturing. The Manufacturing Engineering Manager will lead and manage the other manufacturing engineering personnel at the assigned location to ensure all goals and objectives are achieved.
The Manufacturing Engineering Manager will have many of the same responsibilities as the Engineering Manager but will solely focus on existing products manufactured by Inogen at the assigned location.
Responsibilities (Specific tasks, duties, essential functions of the job)
Responsible for oversight and management of product documentation including packaging drawings, configuration management, deviations, manufacturing validations, labels, field service documentation, and change control
Manufacturing process validations including IQ/OQ/PQ
Oversight and management of manufacturing documentation and maintenance including manufacturing procedures, quality procedures, and equipment evaluations, and equipment calibration / maintenance
Responsible for design control activities associated with manufacturing process revisions and improvements
Leadership, management, and training of other manufacturing engineers, operators, and other manufacturing personnel.
Maintain availability for immediate response to production line issues.
Work with operations personnel to lead coordination of change control and implementation.
Lead pending changes meeting and process to ensure visibility of changes and continuous improvement activities.
Maintain regular and punctual attendance.
Comply with all company policies and procedures.
Assist with any other duties as assigned.
Knowledge, Skills, and Abilities
Must have knowledge or desire to implement and utilize lean manufacturing principles including waste reduction, continuous improvement, standard work, and problem solving
Knowledge of FDA GMP and ISO quality systems.
Experience working in an FDA and ISO 13485 environment.
Attention to detail and follow through required.
Must have a passion for product quality and excellence.
Detail oriented with attention to product quality.
Self-motivating and capable of self-direction.
Good attention to detail and accurate and complete documentation.
Ability to lead and manage other engineers and projects.
Vision and desire to grow the department and its capabilities.
Must have strong work ethic.
Excellent oral and written communication skills required.
Analytical & problem-solving skills & ability to multi-task.
Solutions-oriented problem solver.
Must have interpersonal skills appropriate for interacting with engineering and manufacturing personnel.
Qualifications (Experience and Education)
Bachelor’s degree in Mechanical, Industrial, or related Engineering or Scientific field, required; Master’s degree, preferred.
7+ years of experience in medical device manufacturing, required
2 years’ in a project management role or supervisory/lead role, required
Advance knowledge/proficiency in Microsoft Office and Solidworks Composer, required.
Advance knowledge/proficiency ISO 13485, required.
Expertise in oxygen concentrator design and manufacturing, 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.
