Job Description:We are seeking a highly motivated and independent biomedical engineer who will be responsible for implementation of prototype and production-level product development verification and validation activities associated with the development of the SnapPath™ platform.  The candidate will lead one or more medical device development projects and provide technical input at all stages of the product life cycle.

The successful candidate will have hands-on verification and validation experience as well as a successful track record of commercializing products in regulated environments and be fluent with FDA Design Control and ISO 13485 requirements for medical devices.

Background or experience in the following are essential:

• Assay and platform validation
• Regulatory standards (FDA, ISO) in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes, the Design History File (DHF) and related records
• Project management experience & documentation with design controls and risk analysis

Position Requirements: B.S. or M.S. degree in biomedical engineering from an ABET accredited college with 3-5 years biopharmaceutical or medical device-related industry experience, preferably in oncology or cancer-related product development devices and diagnostics in regulated environments.  Willingness to work with fresh human tissues and live animals are mandatory.   

Work Environment: Shared open office and laboratory space in state-of-the-art biotechnology facility. No relocation funding is available.

If you are interested in one of these Baltimore-area positions, please send your CV/resume to hr@biomarkerstrategies.com