ABOUT THE 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.
Principal Accountabilities:
- Design and develop new sterile barrier packaging for state-of-the-art medical device
- Lead Engineering for Packaging improvements, and support labeling improvements
- Design and coordinate standard engineering tests and experiments for new and current packaging and manufacturing processes
- Ensure packaging and manufacturing 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 manufacturing 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 manufacturing
- 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
- Develop and Implement procedures for manufacturing processes
- Lead Engineers for packaging improvements and lean manufacturing initiatives.
- Provide support to quality team for CAPAs, NCRs, Deviations and SCARs
QUALIFICATIONS:
- Minimum of a B.S degree in an engineering discipline, preferably Packaging, Biomedical or Mechanical Engineering.
- Minimum of 7 years of experience in manufacturing/development environments, with at least 4 years in medical device packaging
- Working knowledge of QSR, cGMP, ISO 14971 and ISO 13485
- Have hands-on experience in CAD package such as Solid Works
- 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
- Ability to perform tolerance stack-up analysis
- Experience in the development and interpretation of SOPs and engineering drawings
- Experience in Packaging 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
All your information will be kept confidential according to EEO guidelines.
