Senior Mechanical Engineer (Biotech Instrumentation)- Gaithersburg, MD

Zachary Piper Solutions is seeking a Senior Mechanical Engineer (Biotech Instrumentation) to join a biomedical manufacturing company located in Gaithersburg, MD through a 100% onsite work environment. The Senior Mechanical Engineer will lead the design, development, and production of complex diagnostic instrumentation used in clinical, biotech, and laboratory settings, contributing hands-on to mechanical and electromechanical systems from concept through high-volume manufacturing.

Responsibilities:

· Lead the 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 (independent contributor level)

· 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: Medical, Dental, Vision, 401K, 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

 Comprehensive Keywords: mechanical engineering, electromechanical systems, instrumentation design, biotech engineering, medical devices, CAD design, SolidWorks, prototyping, hardware development, product lifecycle, manufacturing scale-up, system integration, automation, robotics, microfluidics, motors, motion control, ISO compliance, FDA cGMP, testing and validation, engineering leadership, design controls, sheet metal design, injection molding, thermal systems, mechatronics