Senior Mechanical Engineer; Biotech Instrumentation- Gaithersburg, MD

Senior Mechanical Engineer (Biotech Instrumentation)

Zachary Piper Solutions is seeking a Senior Mechanical Engineer (Biotech Instrumentation) to join a biomedical manufacturing company located in Gaithersburg, MD. The position is 100% onsite.

• Lead end‑to‑end design and development of precision mechanical and electromechanical instrumentation.
• Develop CAD models, engineering drawings, and detailed design documentation using Solid Works.
• Perform hands‑on prototyping, bench assembly, testing, and troubleshooting of systems.
• Collaborate cross‑functionally with electrical, systems, and bioengineering teams to integrate complex subsystems.
• Drive product lifecycle efforts from early concept through mass production and manufacturing scale‑up.
• Develop requirements, specifications, and validation/test protocols for new products.
• Analyze performance data and generate detailed technical reports and design improvements.
• Provide mentorship and technical leadership within a multidisciplinary engineering team.
• Ensure compliance with ISO, FDA cGMP, and regulated product development standards.
• Support vendor selection, component sourcing, and manufacturing process development.

• 12–15+ years of professional mechanical engineering experience as an independent contributor.
• Strong experience with mechanical design, electromechanical systems, and instrumentation development.
• Background in biotech, life sciences, medical devices, fluid systems, or related industry.
• Proven experience bringing hardware products from concept to mass production.
• Hands‑on experience with prototyping, testing, and system integration.
• Proficiency in CAD tools such as Solid Works (or similar) and engineering analysis tools.
• Experience working in ISO/FDA regulated environments.
• Knowledge of manufacturing processes including machining, sheet metal, and injection molding.
• Experience with motors, automation systems, or motion control components.
• Bachelor’s degree in Mechanical Engineering (Master’s preferred).

• Experience with microfluidics or precision fluid systems.
• Mechatronics or robotics experience.
• Exposure to thermal management systems.
• Consumer product design experience involving moving components.
• Familiarity with automation, pick‑and‑place systems, or end‑of‑arm tooling.

• Salary Range: $116,000 – $175,000 depending on experience.
• Comprehensive benefits include medical, dental, vision, 401(k), PTO, sick leave (as required by law), and holidays.
• Annual raises (3–4%) and performance‑based bonus (typically 4–6%, up to 10%).
• Clearance level:
  Must be eligible to work in the United States (no sponsorship available).
• Location:
  
  100% onsite in Gaithersburg, MD.