Senior Mechanical Engineer (Biotech Instrumentation)- Gaithersburg, MD

Job Id: 172146Job Location: Gaithersburg, MarylandSecurity Clearance: No ClearanceBusiness Unit: Zachary PiperPosition Owner: Amanda WiseZachary 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.ResponsibilitiesLead the end-to-end design and development of precision mechanical and electromechanical instrumentation from concept through production releaseCreate system architectures, mechanical designs, and engineering specifications for new products and subsystemsDevelop 3D CAD models, assemblies, engineering drawings, and design documentation using SolidWorksTranslate customer, clinical, and business requirements into engineering requirements and product specificationsDrive design decisions through feasibility studies, risk assessments, and engineering analysisPerform hands-on prototyping, assembly, testing, and design verification activitiesCollaborate with electrical, systems, software, manufacturing, and bioengineering teams to integrate complex subsystems into finished productsLead product development efforts through design reviews, verification, validation, manufacturing transfer, and scale-up activitiesAnalyze design performance data and implement continuous design improvementsMentor junior engineers and provide technical leadership across multidisciplinary project teamsSupport supplier engagement, component selection, DFM initiatives, and manufacturing process developmentEnsure compliance with FDA, ISO, cGMP, and regulated product development standardsRequired QualificationsBachelor's degree in Mechanical Engineering (Master's preferred)12+ years of mechanical engineering experience developing complex hardware productsDemonstrated experience leading mechanical design efforts from initial concept, requirements definition, and architecture through production releaseStrong background in precision mechanical and electromechanical system designExperience creating product requirements, specifications, and design documentation for new product development programsProven track record bringing commercial hardware products from concept through manufacturing scale-up and productionHands-on experience with prototyping, design verification, system integration, and product development testingAdvanced proficiency with SolidWorks or similar 3D CAD platformsExperience working within FDA, ISO, or other regulated product development environmentsKnowledge of manufacturing processes including machining, sheet metal fabrication, injection molding, and assembly methodsExcellent cross-functional collaboration and technical leadership skillsPreferred BackgroundMedical device, biotech, diagnostics, laboratory instrumentation, life sciences, or adjacent high-tech product development industriesExperience with motion systems, automation, robotics, motors, actuators, or precision positioning mechanismsExperience developing fluid handling, microfluidic, or precision flow control systemsFamiliarity with thermal management systems and electromechanical integrationExperience supporting automated manufacturing or laboratory automation platformsCandidate ProfileThe 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 & BenefitsSalary 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 lawWork 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 experienceComprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and HolidaysAnnual raises (3–4%) and performance-based bonus (typically 4–6%, up to 10%)Clearance Level: Must be eligible to work in the United StatesLocation: 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