Senior Mechanical Engineer, Biotech Instrumentation

Piper Companies; Gaithersburg (MD); On-site; USD 116,000 - 175,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

PTO & Holidays

Job summary

Zachary Piper Solutions seeks a Senior Mechanical Engineer (Biotech Instrumentation) in Gaithersburg, MD to lead architecture, design, and development of next‑generation diagnostic and laboratory instrumentation. You will own mechanical product development from concept through commercialization in a regulated setting.

Responsibilities include end-to-end design, system integration with cross-functional teams, and mentoring engineers while ensuring FDA/ISO/cGMP compliance and manufacturing

Qualifications

• 12+ years of mechanical engineering experience developing complex hardware products.
• Experience leading mechanical design from concept through production release.
• Strong background in precision mechanical and electromechanical systems.

Responsibilities

• Lead end-to-end design and development of precision mechanical and electromechanical instrumentation.
• Create system architectures, mechanical designs, and engineering specifications.
• Develop 3D CAD models and engineering drawings using SolidWorks.
• Translate customer and regulatory requirements into engineering specs.
• Drive design decisions through feasibility studies and risk assessments.
• Prototype, assemble, test, and verify designs.
• Collaborate with cross-functional teams to integrate subsystems.
• Lead design reviews, verification, validation, and scale-up activities.
• Mentor junior engineers and drive design improvements.
• Support supplier engagement and manufacturing process development.
• Ensure FDA, ISO, cGMP compliance for regulated development.

Skills

12+ years experience

Leadership

Regulated environments

Requirements analysis

Prototype & testing

Education

Bachelor's degree in Mechanical Engineering

Master's preferred

Tools

SolidWorks

Job description

Zachary Piper Solutions seeks a Senior Mechanical Engineer (Biotech Instrumentation) in Gaithersburg, MD to lead architecture, design, and development of next‑generation diagnostic and laboratory instrumentation. You will own mechanical product development from concept through commercialization in a regulated setting.

Responsibilities include end-to-end design, system integration with cross-functional teams, and mentoring engineers while ensuring FDA/ISO/cGMP compliance and manufacturing