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Job description
Zachary Piper Solutions is seeking a Senior Mechanical Engineer (Biotech Instrumentation) to join a rapidly growing biomedical manufacturing organization in Gaithersburg, MD. This engineer will serve as a key technical contributor responsible for the architecture, design, and development of next-generation diagnostic and laboratory instrumentation. The ideal candidate has deep experience leading mechanical product development from a blank-sheet concept through commercialization and high-volume manufacturing in regulated environments.
This is a highly hands-on role focused on innovative product design, electromechanical systems integration, and technical leadership across multidisciplinary engineering teams.
Responsibilities
Lead the end-to-end design and development of precision mechanical and electromechanical instrumentation from concept through production release
Create system architectures, mechanical designs, and engineering specifications for new products and subsystems
Develop 3D CAD models, assemblies, engineering drawings, and design documentation using SolidWorks
Translate customer, clinical, and business requirements into engineering requirements and product specifications
Drive design decisions through feasibility studies, risk assessments, and engineering analysis
Perform hands-on prototyping, assembly, testing, and design verification activities
Collaborate with electrical, systems, software, manufacturing, and bioengineering teams to integrate complex subsystems into finished products
Lead product development efforts through design reviews, verification, validation, manufacturing transfer, and scale-up activities
Analyze design performance data and implement continuous design improvements
Mentor junior engineers and provide technical leadership across multidisciplinary project teams
Support supplier engagement, component selection, DFM initiatives, and manufacturing process development
Ensure compliance with FDA, ISO, cGMP, and regulated product development standards
Required Qualifications
Bachelor's degree in Mechanical Engineering (Master's preferred)
12+ years of mechanical engineering experience developing complex hardware products
Demonstrated experience leading mechanical design efforts from initial concept, requirements definition, and architecture through production release
Strong background in precision mechanical and electromechanical system design
Experience creating product requirements, specifications, and design documentation for new product development programs
Proven track record bringing commercial hardware products from concept through manufacturing scale-up and production
Hands-on experience with prototyping, design verification, system integration, and product development testing
Advanced proficiency with SolidWorks or similar 3D CAD platforms
Experience working within FDA, ISO, or other regulated product development environments
Knowledge of manufacturing processes including machining, sheet metal fabrication, injection molding, and assembly methods
Excellent cross-functional collaboration and technical leadership skills
Preferred Background
Medical device, biotech, diagnostics, laboratory instrumentation, life sciences, or adjacent high-tech product development industries
Experience with motion systems, automation, robotics, motors, actuators, or precision positioning mechanisms
Experience developing fluid handling, microfluidic, or precision flow control systems
Familiarity with thermal management systems and electromechanical integration
Experience supporting automated manufacturing or laboratory automation platforms
Candidate Profile
The ideal candidate has a strong background in original product design and new product development, rather than primarily sustaining engineering, test engineering, reliability testing, or failure analysis. We are seeking an engineer who has personally owned product architecture, requirements definition, subsystem design, and commercialization efforts for complex instrumentation or hardware products.
Candidates whose experience is heavily focused on military shock/vibration testing, qualification testing, or troubleshooting existing designs without significant ownership of new product creation may not be the strongest fit for this role.
Compensation & Benefits
Salary Range: $116,000 – $175,000 (depending on experience)
Annual merit increases (typically 3–4%), Performance-based bonus program (typically 4–6%, up to 10%)
Medical, Dental, Vision, 401(k), PTO and company holidays, Sick leave as required by law
Work Authorization: Must be authorized to work in the United States.
Work Environment: 100% onsite in Gaithersburg, MD.
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
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
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Worksite address
gaithersburg, MD, 20883, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.