Biomedical Engineer

Job Title: Biomedical Engineer

Location: 101 W Dickman St, Suite 300, Baltimore, MD 21230
Employment Type: Full-time

About Novel Microdevices:

Novel Microdevices is redefining point-of-care diagnostics with cutting-edge diagnostics 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.

Job Summary:

We are looking for a highly motivated and detail-oriented Engineer to lead testing and verification efforts for the Novel Dx device.

In this role, you will operate at the interface of Systems Engineering, integration of mechanical engineering and biochemistry on a complex electromechanical device. You will be supporting a senior biomedical engineer in developing calibration protocols for manufacturing and driving Clinical Verification and Validation (V&V) activities. You will execute test strategies to ensure the device consistently meets performance and regulatory requirements. This role requires excellent manual dexterity, a commitment to quality, and the ability to work efficiently in a fast-paced environment.

Key Responsibilities:

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

Software Development and Support

• 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.

Calibration, Manufacturing Transfer & Process Development

• 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.

Required Qualifications:

• 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

Compensation and Benefits:

• 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.

Additional Information:

• 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.