Sr. Manufacturing Engineer

2 weeks ago

Miami, United States Santen, Inc. Full time

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 deviceLead Engineering for Packaging improvements, and support labeling improvementsDesign and coordinate standard engineering tests and experiments for new and current packaging and manufacturing processesEnsure packaging and manufacturing comply with all regulatory specifications and standardsInvestigate procure and qualify state-of-the-art packaging and labeling equipment for process improvementGenerate and implement validation protocols for existing and new packaging and manufacturing equipmentEnsure records i.e. test reports, evaluations, protocol reports, etc. are created and maintained in accordance with requirements of InnFocus Standard Operating ProceduresApply appropriate problem-solving techniques for effective root cause analysis and successful corrective action for any packaging issueProcess owner for the update of InnFocus Risk Management files relating to packaging and manufacturingProvide manufacturing summary reports for Management Review MeetingsCollaborate with QA and R&D on the qualification of current and future packaging and labeling suppliersDevelop and Implement procedures for manufacturing processesLead 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 packagingWorking knowledge of QSR, cGMP, ISO 14971 and ISO 13485Have hands-on experience in CAD package such as Solid WorksHands-on experience writing and executing validation protocols (IQ/OQ/PQ)Ability to interface with regulatory bodies to present technical informationUnderstand basic applied statistics, statistical sampling plans, and statistical process controlHave knowledge of advance statistical methodologies such as DOEHave knowledge of component qualification and First Article InspectionAbility to perform tolerance stack-up analysisExperience in the development and interpretation of SOPs and engineering drawingsExperience in Packaging designStrong computer skills in the MS office productsAbility to work effectively in a team environmentExcellent technical writing skillsHave knowledge of Design and change controls

Additional Information

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

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