Senior Mechatronics Engineer for Biotech Instrumentation

Zachary Piper Solutions; Gaithersburg (MD); Hybrid; USD 116,000 - 175,000; Full time

Benefits offered by this job

On-site in Gaithersburg

Job summary

Zachary Piper Solutions seeks a Senior Mechanical Engineer (Biotech Instrumentation) to join a fast-growing biomedical manufacturing organization in Gaithersburg, MD. The role emphasizes hands-on design, electromechanical integration, and leadership across engineering teams to bring diagnostic instruments from concept to production.

Ideal candidate has 12+ years in mechanical hardware product development, ownership of architecture and requirements, and proven success in regulated environments.

Qualifications

• Bachelor's degree in Mechanical Engineering (Master's preferred).
• 12+ years of mechanical engineering experience developing complex hardware products.
• Experience leading mechanical design from concept through production release.
• Hands-on prototyping, design verification, system integration and testing.
• Experience bringing hardware from concept through manufacturing scale-up.
• Experience in FDA/ISO/regulatory environments.
• Knowledge of machining, sheet metal, injection molding and assembly.

Responsibilities

• Lead 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, drawings, and design documentation using SolidWorks.
• Translate requirements into engineering requirements and product specifications.
• Drive design decisions through feasibility studies, risk assessments, and analyses.
• Perform prototyping, assembly, testing and design verification.
• Collaborate with electrical, systems, software, manufacturing and bioengineering teams to integrate subsystems.
• Lead product development through design reviews, verification, validation and scale-up.
• Analyze design performance data and drive continuous improvements.
• Mentor junior engineers and provide technical leadership across teams.
• Support supplier engagement, component selection, DFM and manufacturing process development.
• Ensure compliance with FDA/ISO/cGMP and regulatory standards.

Skills

Mechanical design leadership

Regulated environment

Product development ownership

Cross-functional collaboration

System integration

Education

Bachelor's in Mechanical Engineering

Master's preferred

Tools

SolidWorks

Job description

Zachary Piper Solutions seeks a Senior Mechanical Engineer (Biotech Instrumentation) to join a fast-growing biomedical manufacturing organization in Gaithersburg, MD. The role emphasizes hands-on design, electromechanical integration, and leadership across engineering teams to bring diagnostic instruments from concept to production.

Ideal candidate has 12+ years in mechanical hardware product development, ownership of architecture and requirements, and proven success in regulated environments.