What are the responsibilities and job description for the Manufacturing Engineer II position at Senseonics, Incorporated?
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
Salary : $80,000 - $90,000