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Senior Manufacturing Engineer

2 months ago

Miami, Florida, United States Santen Full time
Job 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.

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.

Key Responsibilities
  • Design and develop new sterile barrier packaging for state-of-the-art medical devices.
  • 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, such as 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 teams for CAPAs, NCRs, Deviations, and SCARs.
Requirements
  • 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.
  • Hands-on experience in CAD packages 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 advanced 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.