Process Engineer

Engagement Overview

Process Engineer Job Description

Primary work location = Keene, NH. Occasional travel to and Southington, CT will be required.

Workload

• Two manufacturing equipment systems in development for Southington, CT facility.
• Supported by Keene personnel.
• High speed automation line from supplier in Canada.
• Industrial batch washing/siliconization system from supplier in Italy.
• Automation equipment being transferred from Keene.
• ~ 15 high output automation assembly lines.
• Production support to Keene Operations team
  
  

Responsibilities

• Develop new process for siliconization of syringe plunger tips
• Experiments with legacy equipment to justify elimination of bonding agent and define process output requirements.
• Design verification samples.
• Development of process for new equipment.
• Validation of new equipment and process.
• Support Keene production with sustaining project execution.
• Support design reviews, debug, acceptance and validation activities for equipment being developed by external suppliers.
  
  

Estimated duration: 6 to 9 months

Candidate level: Engineer at E2, E3 or Senior. Open to principal level.

Qualifications

• 4 years’ experience in a medical device manufacturing environment.
• Process development experience.
• Validation experience: IQ, OQ, PQ and TMVs
• Strong background in statistical methods: DOEs, GR&Rs & Process Capability.
• Familiarity with standard MS Office tools.
• Good verbal and written communication skills.
  
  

Additional Desired Qualifications – Not Mandatory

Familiarity with automation assembly systems.