18 days old

Product Development Engineer - EP Cath

Medline Industries, Inc.
Redmond, OR 97756
  • Job Code

Job Description

Medline is currently looking to bring on a Product Development Engineer to join our engineering department in Redmond, OR! This individual will lead projects within our EP catheter development team as we continue to grow. This is a great opportunity to join a fast growing company along with making a positive impact in the world and the lives of others.

Who We Are:

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 learn more: https://www.youtube.com/watch?v=LsdpSjd1fYs&feature=youtu.be

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 solutions.

Here are some of the job duties:

    Participate in development projects following established FDA design control procedures; from feasibility through production implementation, and release to market phases. Develop 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 development efforts. Work with multidisciplinary project teams to ensure projects meet established schedules. May serve as the project lead to direct activities related to product development. Develop and write Standard Operating Procedures (SOPs) for processing devices in production. Engage 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. Effectively communicate cross-functionally within the organization with teammates in: Manufacturing, Quality, Product Management, Marketing, Sales, and Regulatory. Research and understand device functionality, device patents, and clinical use.

Job Qualifications
Required Qualifications:

    Bachelors degree in an Engineering discipline At least 2 years engineering experience Technical writing, research paper writing, and/or experimental design experience ERP systems knowledge and experience Intermediate skill level in computer and systems use (Microsoft Word, PowerPoint, and Excel)
Preferred Qualifications:

    Bachelors degree in Mechanical, Electrical or Biomedical engineering Prior experience working with medical devices; development, reprocessing and/or manufacturing Prior experience working in a FDA regulated industry/field, or similar Exposure to the FDA 510(k) process or other regulatory submissions Experience measuring, conducting testing functions, interpreting and performing test procedures, operating testing equipment and creating/documenting test procedures and results Prior experience in a LEAN Manufacturing/Production environment, GMP and/or New Product Development Prior design experience in CAD using SolidWorks Prior 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 more!

Posted: 2020-03-14 Expires: 2020-04-12
Sponsored by:
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Sponsored by:
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Product Development Engineer - EP Cath

Medline Industries, Inc.
Redmond, OR 97756

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