Senior Manufacturing Engineer

Miami, FL
Oct 08, 2021
Required Education
Masters Degree/MBA
Position Type
Full time

Note: This is a full-time, onsite position, requiring on-premise work at InnFocus in Miami, FL.


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. 


  • Design and develop new sterile barrier packaging for state-of-the-art medical device
  • Lead Engineering for labeling improvements, and support packaging improvements
  • Design and coordinate standard engineering tests and experiments for new and current labeling and packaging processes
  • Ensure labeling and packaging 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 labeling 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 labeling
  • 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
  • Manage and maintain the site UDI system
  • Develop and Implement procedures for manufacturing processes
  • Lead Engineer for labeling improvements 
  • Provide support to quality team for CAPAs, NCRs, Deviations and SCARs


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • 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
  • Have hands-on experience in CAD package such as Solid Works 
  • Ability to perform tolerance stack-up analysis
  • Experience in the development and interpretation of SOPs and engineering drawings
  • Experience in label 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


  • Minimum of a B.S degree in an engineering discipline, preferably Packaging or Mechanical Engineering


  • Minimum of 7 years of experience in manufacturing/development environments, with at least 5 years in medical device packaging 
  • Working knowledge of QSR, cGMP, ISO 14971 and ISO 13485
  • Hands-on experience with UDI


  • Requires onsite work at InnFocus in Miami, FL

COVID-19 Vaccination Requirement: Santen requires anyone working on-site or visiting company offices to confirm they are fully vaccinated against COVID-19 unless a medical or religious accommodation is timely requested and approved. Please reach out if you have questions or concerns about this policy and how it may apply to your candidacy for a role with Santen.

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