Process Engineer II

COMPANY DESCRIPTION: 

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 350-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL). 

Advanced Vision Science, Inc. (AVS) is a California based medical device company specializing in the research, development and manufacturing of ophthalmic medical devices including intraocular lenses and lens material. AVS is a wholly owned subsidiary of Santen Pharmaceutical Co., Ltd, a Japanese company specializing in the development, manufacturing and marketing of ophthalmic products to protect and improve people’s eyesight and health.

AVS has been manufacturing ophthalmic devices since 1975. The AVS quality system is certified to ISO 9001 and ISO 13485. The facility is registered by the US FDA and Japanese MHLW.

PRIMARY PURPOSE OF POSITION:

Provide engineering support to manufacturing group for process stages, efficiency improvement proposals, capacity and resource allocation models, and reducing cost while ensuring compliance with FDA and ISO regulations. Provide engineering support to R&D and manufacturing in relation to new product development and planned process improvements. Responsibilities include troubleshooting, project management, operator training and document initiation/revisions.

MAJOR DUTIES OF POSITION:

• Perform tasks required by the R&D Leadership team
• Interface with internal customers (e.g. manufacturing, engineering, and quality) on various projects (e.g., process validations, CAPAs, deviations, process improvements, etc.)
• Coordinate the qualification of new production testing equipment with special attention to repeatability and reproducibility of measurements
• Develop preventive maintenance and calibration procedures for R&D and production equipment
• Learn manufacturing procedures for all product lines from monomer formulation through sterilization
• Troubleshoot process yield issues using knowledge of statistics and statistical process control
• Troubleshoot manufacturing equipment and production processes including establishing process capability
• Evaluate design changes, specifications and drawing releases relating to manufacturing equipment and processes 
• Perform equipment and process validations to ensure compliance with FDA, PMDA and ISO regulations
• Design and develop new fixturing/tooling to increase efficiencies throughout the production areas
• Work with Production Manager and Leads to develop and implement operating procedures (GMP’s) within the QMS
• Manage projects and studies from concept to completion as required
• Perform IOL testing, analyze data and prepare reports, as needed
• Work with Production Manager to provide support and training for manufacturing operators to improve production outcomes
• Support efforts to reduce lens cost by improving process flow and capacity
• Document all work in accordance with the requirements of the AVS Quality System

KNOWLEDGE AND SKILL REQUIREMENTS:

• BS in engineering or physics
• 2 – 5 years of experience in medical device industry 
• Experienced in the use of statistics, problem solving techniques, and control charting
• Six sigma certification preferred
• Strong analytical skills and working knowledge of analytical instrumentation 
• Ability to perform recurring characterization/measurements of large-scale samples
• Knowledge in Solidworks and 3D printing helpful
• Operational knowledge of machine shop equipment (E.g. lathe, mill, drill press) for prototype development helpful
• Familiar with safety procedures in laboratory environments
• Familiar with ISO/FDA/GMP environment for medical devices
• Possess solid computer skills.    Must be proficient in
  • Excel – create and work with spreadsheets
  • Word –     create and format professional correspondence
  • PowerPoint – create meeting presentations
  • Outlook – email & maintain company calendars.
• Strong verbal and written communications skills
• Excellent technical writing skills essential
• Strong creative skills to develop new solutions and products ideas
• Ability to prioritize multiple projects