Manufacturing Engineer II

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 use
• Thorough working knowledge of manufacturing operations principles and cGMP.
• Basic working knowledge of process validation principles
• Demonstrated ability to drive cost improvement and scale-up projects working in or leading cross-functional teams
• Direct experience with regulated environments (i.e. ISO 13485, Notified Bodies, GMP, OSHA, EPA) required
• Lean Six Sigma or DFSS training, Green Belt or Black Belt preferred
• ETO Sterilization experience is a plus