Senior Mechanical Engineer II

Job Title: Senior Mechanical Engineer II

Location: Gaithersburg, MD (Onsite)

Hours/

Schedule:

Monday – Friday, Standard Business Hours

Compensation: $115,000 – $140,000 + bonus eligibility

Type: Direct Hire

A growing life sciences and bioprocessing organization is seeking a Senior Mechanical Engineer II to support the design and development of advanced mechanical systems and sterile consumable technologies used in GMP manufacturing environments. This is a highly collaborative, hands‑on engineering role offering exposure to innovative bioprocessing technologies, cross‑functional development teams, and complex product development initiatives.

• Lead mechanical design and development for GMP manufacturing systems and consumables
• Create CAD models, drawings, BOMs, and ECOs in Solid Works
• 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

• B.S. in Mechanical Engineering required; M.S. preferred
• 8+ years of mechanical design experience
• 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 Solid Works; PDM experience preferred
• Familiarity with DFx, manufacturability, reliability, and cost optimization
• Experience with bioprocessing systems such as bioreactors or filtration technologies
• FEA experience preferred; 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 preferred (CNC, molding, 3D printing, etc.)
• Strong communication, collaboration, and problem‑solving skills
• Ability to travel domestically up to 10–15%

Our client provides a comprehensive benefits package including medical, dental, and vision coverage, retirement savings options, paid time off, professional development opportunities, and bonus eligibility.