Manufacturing Engineer

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 continuous process improvements.

• Develop and Implement procedures for manufacturing processes
• Provide support to quality team for CAPAs, NCRs, Deviations and SCARs
• Apply appropriate problem-solving techniques for effective root cause analysis and successful corrective action for any manufacturing issue
• Investigate and procure state-of-the-art manufacturing equipment for manufacturing process improvement
• Implement validation protocols for existing equipment, test method validations and Gage R&R
• Ensure records i.e. test reports, evaluations, protocol reports, etc. are created and maintained in accordance with requirements of InnFocus Standard Operating Procedures 
• Manage, maintain and update InnFocus Risk Management files
• Provide manufacturing summary reports for Management Review Meetings 
• Collaborate with QA and R&D on the qualification of current and future manufacturing suppliers
• Mentor junior engineers in the medical device manufacturing processes and techniques
• Manage the effective operation of the cleanroom by implementing ergonomic improvements

• Minimum of a B.S degree in an engineering discipline, preferably Biomedical, Industrial or Mechanical Engineering
• Minimum of 3 years of experience in manufacturing/development environments, with at least 2 years in medical device packaging 
• Working knowledge of QSR, cGMP, ISO 14971 and ISO 13485
• Hands-on experience writing and executing validation protocols (IQ/OQ/PQ/TMV/SV)
• 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, Work Instructions (WIs) and engineering drawings
• 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

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.