Senior Mechanical Engineer; Biotech Instrumentation- Gaithersburg, MD

Position: 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 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

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 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)

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