Job Description

We are currently looking for an Associate Manufacturing Engineer to join our Medical Device facility in Miami, FL.

What you will do
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.

• 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

Qualifications

What you will bring to the role

• 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

Additional Information

Grow your career at Santen
A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.

What we offer:

The salary range for the Associate Manufacturing Engineer position is ** $** ** 75,120 - $93,900** depending on experience

Would you like to learn more about this position. Apply now.