Senior Mechanical Engineer (Biotech Instrumentation)- Gaithersburg, MD - 172146

Responsibilities: Lead the end-to-end design and development of precision mechanical and electromechanical instrumentation from concept through production release Create system architectures, mechanical designs, and engineering specifications for new products and subsystems Develop 3D CAD models, assemblies, engineering drawings, and design documentation using SolidWorks Translate customer, clinical, and business requirements into engineering requirements and product specifications Drive design decisions through feasibility studies, risk assessments, and engineering analysis Perform hands-on prototyping, assembly, testing, and design verification activities Collaborate with electrical, systems, software, manufacturing, and bioengineering teams to integrate complex subsystems into finished products Lead product development efforts through design reviews, verification, validation, manufacturing transfer, and scale-up activities Analyze design performance data and implement continuous design improvements Mentor junior engineers and provide technical leadership across multidisciplinary project teams Support supplier engagement, component selection, DFM initiatives, and manufacturing process development Ensure compliance with FDA, ISO, cGMP, and regulated product development standards Required Qualifications Bachelor's degree in Mechanical Engineering (Master's preferred) 12+ years of mechanical engineering experience developing complex hardware products Demonstrated experience leading mechanical design efforts from initial concept, requirements definition, and architecture through production release Strong background in precision mechanical and electromechanical system design Experience creating product requirements, specifications, and design documentation for new product development programs Proven track record bringing commercial hardware products from concept through manufacturing scale-up and production Hands-on experience with prototyping, design verification, system integration, and product development testing Advanced proficiency with SolidWorks or similar 3D CAD platforms Experience working within FDA, ISO, or other regulated product development environments Knowledge of manufacturing processes including machining, sheet metal fabrication, injection molding, and assembly methods Excellent cross-functional collaboration and technical leadership skills Preferred Background Medical device, biotech, diagnostics, laboratory instrumentation, life sciences, or adjacent high-tech product development industries Experience with motion systems, automation, robotics, motors, actuators, or precision positioning mechanisms Experience developing fluid handling, microfluidic, or precision flow control systems Familiarity with thermal management systems and electromechanical integration Experience supporting automated manufacturing or laboratory automation platforms Candidate Profile The ideal candidate has a strong background in original product design and new product development, rather than primarily sustaining engineering, test engineering, reliability testing, or failure analysis. We are seeking an engineer who has personally owned product architecture, requirements definition, subsystem design, and commercialization efforts for complex instrumentation or hardware products. Candidates whose experience is heavily focused on military shock/vibration testing, qualification testing, or troubleshooting existing designs without significant ownership of new product creation may not be the strongest fit for this role. Qualifications: Bachelor's degree in Mechanical Engineering (Master's preferred) 12+ years of mechanical engineering experience developing complex hardware products Demonstrated experience leading mechanical design efforts from initial concept, requirements definition, and architecture through production release Strong background in precision mechanical and electromechanical system design Experience creating product requirements, specifications, and design documentation for new product development programs Proven track record bringing commercial hardware products from concept through manufacturing scale-up and production Hands-on experience with prototyping, design verification, system integration, and product development testing Advanced proficiency with SolidWorks or similar 3D CAD platforms Experience working within FDA, ISO, or other regulated product development environments Knowledge of manufacturing processes including machining, sheet metal fabrication, injection molding, and assembly methods Excellent cross-functional collaboration and technical leadership skills Preferred Background Medical device, biotech, diagnostics, laboratory instrumentation, life sciences, or adjacent high-tech product development industries Experience with motion systems, automation, robotics, motors, actuators, or precision positioning mechanisms Experience developing fluid handling, microfluidic, or precision flow control systems Familiarity with thermal management systems and electromechanical integration Experience supporting automated manufacturing or laboratory automation platforms Candidate Profile The ideal candidate has a strong background in original product design and new product development, rather than primarily sustaining engineering, test engineering, reliability testing, or failure analysis. We are seeking an engineer who has personally owned product architecture, requirements definition, subsystem design, and commercialization efforts for complex instrumentation or hardware products. Candidates whose experience is heavily focused on military shock/vibration testing, qualification testing, or troubleshooting existing designs without significant ownership of new product creation may not be the strongest fit for this role.