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Manufacturing Engineer II
Manufacturing Engineer IISenseonics Incorporated • Germantown, MD, US
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Manufacturing Engineer II

Manufacturing Engineer II

Senseonics Incorporated • Germantown, MD, US
1 day ago
Job type
  • Full-time
Job description

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 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
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    Manufacturing Engineer Ii • Germantown, MD, US

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