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Senior Process Engineer (Process Development)

Senseonics Incorporated Germantown, MD

  • Posted: over a month ago
  • Full-Time
Job Description

Job Summary:

We are looking for a high-performing individual that will drive the development of medical device manufacturing processes from prototype assembly to production manufacturing. 

Duties and Responsibilities include, but are not limited to:

  • Responsible for improvement, optimization, and implementation of manufacturing process/assembly and operating procedures for replicate equipment and processes within a regulated quality system.
  • Lead and support equipment/process qualifications including protocol development and execution.
  • Develop and maintain project timelines and provide updates and feedback to management.
  • Development of production test systems and test plans in accordance with regulatory standards.
  • Plan and perform design of experiments and utilize Lean/Six Sigma methodologies for improved and new processes.
  • Sensor data analysis-perform statistically robust analysis of data and report on findings. 
  • Support activities for regulatory submissions and quality compliance.

Knowledge, Skills, Abilities and Requirements:

  • BS degree (minimum) or higher (MS or Ph.D. preferred) in the Engineering Sciences (i.e., Chemical, Mechanical, Electrical, Physics, etc.) 
  • Minimum 5+ years’ experience in a regulated medical manufacturing environment (7+years preferred)
  • Knowledge of production unit operations and test systems 
  • Failure mode effects analysis experience for root cause analysis
  • Six Sigma/Lean principles experience (green belt, with black belt preferred)
  • Proficient in minitab and Microsoft office suite
  • Direct experience with regulated environments (i.e., ISO 13485, 21 CFR 820, Notified Bodies, GMP, OSHA, EPA) required

Senseonics Incorporated

Address

Germantown, MD
20876 USA

Industry

Manufacturing

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