Associate Manufacturing Engineer

Santen • Miami, FL

288d • $75,120 - $93,900

About The Position

We are currently looking for an Associate Manufacturing Engineer to join our Medical Device facility in Miami, FL. This is a hands-on position providing engineering support to the manufacturing production area including qualifying new equipment, validating production processes and inspection methods, and managing continuous process improvements.

Requirements

• Minimum of 1-3 years of experience in manufacturing/development environments, with at least 2 years in medical device industry
• Working knowledge of QSR, QMS, cGMP, ISO 14971 and ISO 13485
• Hands-on experience in executing validation protocols (IQ/OQ)
• 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
• Ability to perform tolerance stack-up analysis
• Experience in the development and interpretation of SOPs, Work Instructions (WIs) and engineering drawings
• Excellent technical writing skills
• Have knowledge of Design and change controls

Responsibilities

• Develop and Implement procedures for manufacturing processes
• Lead and 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
• Support labeling, packaging improvements and new markets launches
• 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
• Manage the effective operation of the cleanroom by implementing ergonomic improvements

Benefits

• Salary range for the Associate Manufacturing Engineer position is $75,120 - $93,900 depending on experience

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services