Sr. Manufacturing Engineer - Packaging - Santen, Inc.

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 300-total staff in North America, including our Toronto, Canada site and our recent acquisition of  InnFocus (Miami, FL).

Job Description

ABOUT THE POSITION:

This is a hands-on position providing engineering support to the manufacturing production area including qualifying new equipment, validating production and inspection processes, and managing packaging and labeling in all areas of sterile and non-sterile product packaging.

Principal Accountabilities:

• Design and develop new sterile barrier packaging for state-of-the-art medical device
• Lead Engineering for Packaging improvements, and support labeling improvements
• Design and coordinate standard engineering tests and experiments for new and current packaging and manufacturing processes
• Ensure packaging and manufacturing comply with all regulatory specifications and standards
• Investigate procure and qualify state-of-the-art packaging and labeling equipment for process improvement
• Generate and implement validation protocols for existing and new packaging and manufacturing equipment
• Ensure records i.e. test reports, evaluations, protocol reports, etc. are created and maintained in accordance with requirements of InnFocus Standard Operating Procedures
• Apply appropriate problem-solving techniques for effective root cause analysis and successful corrective action for any packaging issue
• Process owner for the update of InnFocus Risk Management files relating to packaging and manufacturing
• Provide manufacturing summary reports for Management Review Meetings
• Collaborate with QA and R&D on the qualification of current and future packaging and labeling suppliers
• Develop and Implement procedures for manufacturing processes
• Lead Engineers for packaging improvements and lean manufacturing initiatives.
• Provide support to quality team for CAPAs, NCRs, Deviations and SCARs

Qualifications

QUALIFICATIONS:

• Minimum of a B.S degree in an engineering discipline, preferably Packaging, Biomedical or Mechanical Engineering.
• Minimum of 7 years of experience in manufacturing/development environments, with at least 4 years in medical device packaging
• Working knowledge of QSR, cGMP, ISO 14971 and ISO 13485
• Have hands-on experience in CAD package such as Solid Works
• Hands-on experience writing and executing validation protocols (IQ/OQ/PQ)
• Ability to interface with regulatory bodies to present technical information
• Understand basic applied statistics, statistical sampling plans, and statistical process control
• Have knowledge of advance statistical methodologies such as DOE
• Have knowledge of component qualification and First Article Inspection
• Ability to perform tolerance stack-up analysis
• Experience in the development and interpretation of SOPs and engineering drawings
• Experience in Packaging design
• Strong computer skills in the MS office products
• Ability to work effectively in a team environment
• Excellent technical writing skills
• Have knowledge of Design and change controls

Additional Information

All your information will be kept confidential according to EEO guidelines.