Senior Mechanical Engineer (Biotech Instrumentation)- Gaithersburg, MD

Zachary Piper Solutions; Gaithersburg (MD); Hybrid; USD 116,000 - 175,000; Full time

Benefits offered by this job

On-site in Gaithersburg

Job summary

Zachary Piper Solutions seeks a Senior Mechanical Engineer (Biotech Instrumentation) to join a fast-growing biomedical manufacturing organization in Gaithersburg, MD. The role emphasizes hands-on design, electromechanical integration, and leadership across engineering teams to bring diagnostic instruments from concept to production.

Ideal candidate has 12+ years in mechanical hardware product development, ownership of architecture and requirements, and proven success in regulated environments.

Qualifications

• Bachelor's degree in Mechanical Engineering (Master's preferred).
• 12+ years of mechanical engineering experience developing complex hardware products.
• Experience leading mechanical design from concept through production release.
• Hands-on prototyping, design verification, system integration and testing.
• Experience bringing hardware from concept through manufacturing scale-up.
• Experience in FDA/ISO/regulatory environments.
• Knowledge of machining, sheet metal, injection molding and assembly.

Responsibilities

• Lead 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, drawings, and design documentation using SolidWorks.
• Translate requirements into engineering requirements and product specifications.
• Drive design decisions through feasibility studies, risk assessments, and analyses.
• Perform prototyping, assembly, testing and design verification.
• Collaborate with electrical, systems, software, manufacturing and bioengineering teams to integrate subsystems.
• Lead product development through design reviews, verification, validation and scale-up.
• Analyze design performance data and drive continuous improvements.
• Mentor junior engineers and provide technical leadership across teams.
• Support supplier engagement, component selection, DFM and manufacturing process development.
• Ensure compliance with FDA/ISO/cGMP and regulatory standards.

Skills

Mechanical design leadership

Regulated environment

Product development ownership

Cross-functional collaboration

System integration

Education

Bachelor's in Mechanical Engineering

Master's preferred

Tools

SolidWorks

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