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 Overview 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. 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 Requirements • 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 SolidWorks; 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% Benefits 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. #M-3 Ref: #558-Scientific