Senior Mechanical Engineer II, Gaithersburg, MD

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.

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System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.