Associate Manufacturing Engineer
Associate Manufacturing Engineer
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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 handson 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 problemsolving techniques for effective root cause analysis and successful corrective action for any manufacturing issue
- Investigate and procure stateoftheart 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 13 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
- Handson 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 stackup 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 longterm 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 $75120 $93900 depending on experience
Would you like to learn more about this position. Apply now.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
