Medline ReNewal is a single
use medical device (SUD) commercial reprocessor. We collect used SUDs
from healthcare facilities nationwide at our newly commissioned facility
in Redmond Oregon and remanufacture them to meet or exceed the performance
specifications of a new original equipment device. Watch this quick video to
Our Product Development
Engineers, following guidance from the FDA, develop validated production
processes that enable the disassembly, cleaning, disinfection, functional
testing, repackaging and sterilization of SUDs. The result is a reprocessed SUD
that provides the highest level of patient care, reduces medical waste, and is
sold for half the price of a new device. Our engineers are eager problem
solvers that use common sense with a hands-on approach when providing
Here are some of the job duties:
in development projects following established FDA design control
procedures; from feasibility through production implementation, and
release to market phases.
and execute validation strategies for medical device cleaning,
biocompatibility, functional performance and packaging studies that
challenge the status quo. Write protocols, validation plans,
procedures, analyses and reports. Create and maintain the design
history file (DHF) and any other records created as part of the
with multidisciplinary project teams to ensure projects meet established
schedules. May serve as the project lead to direct activities related to
and write Standard Operating Procedures (SOP’s) for processing devices in
outside contracting services in support of project needs, i.e. analytical
laboratories, consultants, material suppliers and equipment
suppliers. Build effective relationships with these resources
to meet delivery and budgetary goals.
communicate cross-functionally within the organization with teammates in:
Manufacturing, Quality, Product Management, Marketing, Sales, and
and understand device functionality, device patents, and clinical use.
in an Engineering discipline.
skill level in computer and systems use (Microsoft Word, PowerPoint, and
degree in Mechanical, Electrical or Biomedical engineering.
experience working with medical devices; development, reprocessing and/or
experience working in a FDA regulated industry/field, or similar.
to the FDA 510(k) process or other regulatory submissions.
measuring, conducting testing functions, interpreting and performing test
procedures, operating testing equipment and creating/documenting test
procedures and results.
experience in a LEAN Manufacturing/Production environment, GMP and/or New
design experience in CAD using SolidWorks.
experience reading and interpreting standards and guidance documents.
Medline offers a business casual,
entrepreneurial work environment with strong growth potential, a competitive
compensation package, and a complete benefits package including
medical/dental/vision/life insurance; 401(k) with company match. And much