Senior Mechanical Engineer – GMP Bioprocess Systems

Energy Jobline ZR; Gaithersburg (MD); On-site; USD 115,000 - 140,000; Full time

Benefits offered by this job

Health benefits

Retirement savings

Paid time off

Professional development

Bonus eligibility

Job summary

Energy Jobline ZR is seeking a Senior Mechanical Engineer II in Gaithersburg, MD to lead the design of GMP manufacturing systems and sterile consumables. You will create SolidWorks models, perform tolerance and FEA analyses, and drive validation activities across cross-functional teams.

The role requires 8+ years of mechanical design experience in regulated environments, with hands-on work on sterile single-use systems and bioprocessing technologies.

Qualifications

• BS in Mechanical Engineering; MS preferred
• 8+ years of mechanical design experience in regulated environments
• Experience in medical device, bioprocessing, pharma, or regulated industries
• Hands-on experience with sterile single-use systems or fluid assemblies
• Strong knowledge of fluid systems, pumps, valves, manifolds, and flow paths
• Experience with sealing interfaces, tolerance analysis, and complex mechanical systems
• Proficient in SolidWorks; PDM experience
• Familiarity with DFx, manufacturability, reliability, and cost optimization
• Experience with bioprocessing systems such as bioreactors or filtration technologies
• FEA experience; COMSOL is a plus
• Knowledge of GMP environments and cleanroom-compatible design
• Familiarity with ISO 13485, ISO 9001, ISO 10993, ISO 14971, and design controls
• Experience with validation, testing, and engineering documentation
• Prototyping and fabrication experience (CNC, molding, 3D printing)
• Strong communication, collaboration, and problem-solving skills
• Ability to travel domestically up to 10–15%

Responsibilities

• Lead mechanical design and development for GMP manufacturing systems and consumables
• Create CAD models, drawings, BOMs, and ECOs in SolidWorks
• Perform tolerance analysis, FEA, and root cause investigations
• Support prototyping, testing, and design verification activities
• Design sterile single-use bioprocessing and fluid handling systems
• Develop and execute validation and testing protocols
• Support design transfer and DHF documentation
• Collaborate with engineering, manufacturing, quality, and suppliers
• Mentor junior engineers and provide technical guidance
• Ensure compliance with GMP, regulatory, and engineering standards
• Develop SOPs and engineering documentation

Skills

SolidWorks

FEA

PDM

CAD modeling

Prototyping

Education

B.S. in Mechanical Engineering

M.S. preferred

Tools

SolidWorks

COMSOL

Job description

Energy Jobline ZR is seeking a Senior Mechanical Engineer II in Gaithersburg, MD to lead the design of GMP manufacturing systems and sterile consumables. You will create SolidWorks models, perform tolerance and FEA analyses, and drive validation activities across cross-functional teams.

The role requires 8+ years of mechanical design experience in regulated environments, with hands-on work on sterile single-use systems and bioprocessing technologies.