Medical Manufacturing Engineer

POSITION:
Manufacturing Engineer

Concordia Medical is an innovator and manufacturer of specialty fiber based medical implants and scaffolds for regenerative medicine. With our extensive experience in the development and GMP manufacture of biomedical implants, which consist of bioresorbable and/or non-resorbable fibers for tissue-engineering applications, Concordia Medical is working with academic research partners and medical device industry leaders to develop the next generation of medical implants. The company recently announced expanded uses of its newest product line, BIOFELT™, a versatile bioresorbable polymer scaffold that can be used in PMA devices for tissue engineering and cell-seeding, as well as 510(k) medical implant applications. Concordia Medical is ISO 13485:2003 certified for medical device design and manufacturing.

To meet the growing demand for our current and next generation products Concordia Medical is looking for an experienced Medical Manufacturing Engineer to join our growing team of industry experts.

In this position you will support new product development and process improvement projects. A summary of some of the responsibilities include:

Develop and document new manufacturing methods to support new products or process improvements
Provide problem solving leadership and comprehensive root cause analysis
Setup and run process experimentation using applicable six sigma tools for test setup and analysis.
Interact with manufacturing personnel to get input and conduct training on new equipment and processes.
Work with Quality to ensure appropriate test methods and validation protocols are created and utilized
Develop and create any custom fixturing to support new products or improve existing processes.
Work with customers on new product concepts using FMEA analysis and implementing DFM principles.
Work with new materials to ensure proper qualification/validation prior to release to manufacturing.
Prepare formal reports for assigned tasks outlining all test methods, data, results and conclusions

Qualifications:

BS in Industrial or Mechanical Engineering
Five years experience as a Manufacturing or Process Engineer in a medical device contract manufacturing operation.
Prefer experience in the manufacturing of implantable medical fabrics.
Proven history of using six sigma skills on successful projects, including Gauge R&R (MSE), Capability Studies, DOE.
Experience in lean manufacturing and setting up efficient work cells