Specialist in medical device reprocessing

at GE Healthcare (view profile)
Location Milwaukee, Wisconsin
Date Posted April 29, 2020
Category Medical Device
Job Type Full-time
Address 9900 W Innovation Drive


Role Summary:

In this role you will collaborate with the GE Healthcare Technology teams, research sites, clinical partners and laboratories specialized in testing medical devices as the SME for reprocessing, cleaning and disinfection to innovate on designs for new products to meet customer and regulatory requirements for reprocessing

Essential Responsibilities:

In this role, you will be responsible for the design and qualification of processing methods for reusable ultrasound probes, ensuring that the products reach all design goals required to meet the needs of the customer and regulatory requirements including: features and functionality, quality, reliability, service convenience and regulatory compliance.
You will need to create the strategy for reprocessing, verification and validation of the products for use in a clinical environment, and work with the laboratories to execute on the strategy
• Combining biomedical knowledge of clinical requirements for the ultrasound and reprocessing in order to improve the specifications and design of the product.
• Participating in product definition and reprocessing procedures, verification and validation. Planning and executing tests in cooperation with product development teams and external laboratories Preparing test protocol validation, modifications and reports.
• Writing reprocessing instructions in official documents that are included in the user manual, and validate the reprocessing instructions.
• Maintaining the database and updating information communicated to the client, in hardcopy and through maintaining the website


- Bachelor's Degree in Engineering/Science or bachelors Degree and 2 years experience within
technical discipline or equivalent (defined as High School Diploma/GED and 4 years progressive
experience as an engineer, scientist within the appropriate field of study or within technical
systems designs)
- 5 years progressive experience as an engineer or scientist within the appropriate field of study
- 3 year experience in project leadership within a manufacturing, development or research
- good understanding and grasping of user expectations in the requirements of the product

U.S. (Country) Specific Qualifications:

1.Must be legally authorized to work in the United States full-time
2.Must be willing to work in our [city, state] facility full-time
3.Must submit application for employment through gecareers.com (or COS if internal) to be
4.Must be 18 years of age or older
5.Must be willing to take a drug test as part of the selection process
6.Must be willing to submit to a background investigation, including for example, verification of
your past employment, criminal history, and educational background

Desired Characteristics:

- Master's degree in chemistry, biomedical engineering, biology or pharmacy
- Excellent speaking and writing communication skills
- Experience in collaborative research
- Spirit of initiative, knowing how to motivate, concentrating on goals and able to multistage
- Proven ability to solve problems and being results-oriented
- Knowledge of regulations
° AAMI TIR 12: 2010 Designing, testing, and labeling reusable medical devices for repressing in
health care facilities: A guide for medical device manufacturers
° ISO 17664: 2004 Sterilization of medical devices â Information to be provided by the
manufacturer for processing re-sterilizable medical devices
° ISO/TS 15883-5: 2005 Washer-Disinfectors â Part 5 â Test soils and methods for demonstrating
cleaning efficacy
° FDA Guidance: 1996 (as amended), Labeling Reusable Devices for Processing in Healthcare
Facilities â Reviewer Guidance
° ISO 10993 series

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