Senior Mechanical Engineer - Biotech Instrumentation Lead

ZP Group; Gaithersburg (MD); On-site; USD 116,000 - 175,000; Full time

Job summary

Zachary Piper Solutions is seeking a Senior Mechanical Engineer (Biotech Instrumentation) to join a rapidly growing biomedical manufacturing organization in Gaithersburg, MD. This hands-on role focuses on architecture, design, and development of next-generation diagnostic and laboratory instrumentation, with experience leading mechanical product development from concept through commercialization.

The ideal candidate will lead cross-functional teams, develop 3D CAD models in SolidWorks, ensure

Qualifications

• Bachelor's degree in Mechanical Engineering; master's preferred.
• 12+ years of mechanical engineering experience in hardware products.
• Experience leading design from concept through production release.
• Experience in regulated environments (FDA/ISO/cGMP).
• Prototyping, design verification, and system integration expertise.
• Strong cross-functional leadership and collaboration.

Responsibilities

• Lead end-to-end design and development of mechanical and electromechanical instrumentation from concept to production release.
• Create system architectures and mechanical designs with engineering specifications.
• Develop 3D CAD models and drawings using SolidWorks.
• Translate customer and regulatory requirements into engineering specs.
• Drive design decisions via feasibility studies, risk assessments, and analyses.
• Prototype, test, and verify designs; support manufacturing transfers and scale-up.
• Collaborate with electrical, software, manufacturing, and bioengineering teams.
• Mentor junior engineers and provide technical leadership.
• Ensure compliance with FDA, ISO, cGMP and related standards.

Skills

Mechanical design

Electromechanical systems

Design leadership

Product development

Cross-functional collaboration

Mentoring

Education

Bachelor's degree in Mechanical Engineering

Master's degree preferred

Tools

SolidWorks

Job description

Zachary Piper Solutions is seeking a Senior Mechanical Engineer (Biotech Instrumentation) to join a rapidly growing biomedical manufacturing organization in Gaithersburg, MD. This hands-on role focuses on architecture, design, and development of next-generation diagnostic and laboratory instrumentation, with experience leading mechanical product development from concept through commercialization.

The ideal candidate will lead cross-functional teams, develop 3D CAD models in SolidWorks, ensure