What are the responsibilities and job description for the Senior Mechanical Engineer II position at System One?
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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Ref: #558-Scientific
Salary : $115,000 - $140,000