Senior Manufacturing Engineer

Location
Miami, FL
Posted
Oct 08, 2021
Ref
1165
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.

PRIMARY PURPOSE OF 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. 

MAJOR DUTIES OF POSITION: 

  • 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

KNOWLEDGE AND SKILL REQUIREMENTS:

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

EDUCATION:

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

EXPERIENCE:

  • 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

Location: 

  • 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.

For more information about our company and the work experience, please visit www.santenusa.com and https://www.santenusa.com/career-culture