Biomedical Engineer at Novel Microdevices Baltimore, MD

Overview

Job Title: Biomedical Engineer

Location: 101 W Dickman St, Suite 300, Baltimore, MD 21230

Employment Type: Full-time

Novel Microdevices is redefining point-of-care diagnostics with cutting-edge diagnostic products designed for rapid, reliable, and actionable medical insights. Our team is building next-generation diagnostic platforms using embedded systems, real-time image processing, and cloud-integrated data solutions to empower healthcare professionals worldwide.

• Device Assembly and Hands-on testing support
• Operate basic mechanical assembly tools to support routine instruments and subassembly builds
• Perform assembly activities in accordance with approved SOPs, work instructions, and established procedures
• Develop new SOPs and revise existing procedures to document assembly methods, process improvements, and best practices
• Define and document acceptance and rejection criteria for instruments, components, and subassemblies
• Build working expertise in instrument subassemblies, including their functions, interfaces, and impact on overall system performance
• Provide day-to-day hands-on support to the testing team, including making on-demand changes to instrument control parameters as needed during test execution
• Investigate, document, and communicate defects, working with all stakeholders in the team to drive timely resolution and prevent recurrence
• Develop foundational wet lab skills to support testing, sample handling, and related laboratory activities
• Support Corrective and Preventive Actions (CAPA) investigations and documentation arising from V&V activities

• Investigate unexpected events, issues, or software bugs
• Collaborate in cross-functional teams to trouble-shoot complex system-level field complaints
• Report to team leadership on investigation outcome and recommend test plan. Verify fixes
• Complete software testing and activities for development of user stories
• Perform exploratory testing, system level end to end testing, develop test datasets and execute automation scripts (to ensure application software releases are of high quality)
• Evaluate test cases for automation suitability and execute conversion as required
• Maintain documentation and support other team members to maintain Design History Files (DHF) in compliance with FDA 21 CFR 820 and applicable standards for 510(k) submissions

• Work towards development of calibration and validate calibration procedures for instruments and subsystems
• Ensure calibration processes are robust, repeatable, and transferable to manufacturing technicians
• Define and document acceptance/rejection criteria for instruments and subassemblies
• Provide training and documentation to support manufacturing and quality teams
• Support design transfer activities, ensuring smooth transition from development to production

• Background in biomedical, systems, or electrical/mechanical engineering which translates into cross functional ability to work with electronics/firmware and able to understand biological systems to run assays on a microfluidic device and interpret the data
• 2+ years of relevant industry experience working with Medical Devices (IVD preferred)
• Familiarity with FDA design controls, ISO 13485, and risk management standards
• Strong systems thinking and communication skills to work across hardware, software, and biological interfaces

• Bi-weekly pay schedule
• Eligible for the Company's Employee Stock Option Incentive Plan
• Access to standard benefits package including healthcare and other company-offered plans

• Employment is at-will
• Role is in-person and due to the nature of the work, it cannot be supported adequately from a remote location
• Must be authorized to work in the United States