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. Responsibilities Lead end‑to‑end design and development of precision mechanical and electromechanical instrumentation. Develop CAD models, engineering drawings, and detailed design documentation using SolidWorks. 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. Qualifications 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 SolidWorks (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). Nice to Have 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. Compensation 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. #J-18808-Ljbffr Zachary Piper Solutions