Senior Mechanical Engineer (Biotech Instrumentation)- Gaithersburg, MD

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

Requirements

• 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