Job Description
Job Description
Job Summary :
The manufacturing engineer II is expected to be a high-performing individual who will either directly or indirectly manage Senseonics’ contract manufacturers to ensure supply chain continuity. The manufacturing engineer II will work to optimize yields, improve manufacturing & business processes to increase supply chain robustness and reduce cost.
Duties and Responsibilities include, but are not limited to :
- Directly manage or provide support for production activities for one or more value streams of the continuous glucose monitoring system.
- Directly maintain or support monthly production schedule updates with the external vendors to meet or exceed demand volumes
- Identify cost reduction opportunities and work as team toward implementation.
- Contributes to or solely designs, implements and optimizes manufacturing or business processes.
- Contributes to the development of specifications for raw materials, production processes and production output.
- Maintains and works to improve KPIs at CMOs.
- Act as primary or secondary author for product DHRs and WIP / finished good testing forms.
- Complete ECR / ECOs to support continuous improvement activates and product launches.
- Work with R&D / Development teams to implement continuous improvements into manufacturing or business processes
- Communicates manufacturing capabilities, production schedules, or other information to facilitate production processes
- Supports activities for regulatory submissions
- Supports activities for quality audits
- The company reserves the right to add or change duties at any time
Knowledge, Skills, Abilities, and Requirements :
BS degree or higher in Industrial, Mechanical, Chemical, Electrical engineering or related field.5+ years of experience and / or a combination of education in a regulated medical manufacturing environment coupled with equipment and processes utilized to manufacture products for medical useThorough working knowledge of manufacturing operations principles and cGMP.Basic working knowledge of process validation principlesDemonstrated ability to drive cost improvement and scale-up projects working in or leading cross-functional teamsDirect experience with regulated environments (i.e. ISO 13485, Notified Bodies, GMP, OSHA, EPA) requiredLean Six Sigma or DFSS training, Green Belt or Black Belt preferredETO Sterilization experience is a plus