Senior Engineer- Greater Potomac, MD

Senior Engineer

A growing life sciences organization is seeking a Senior Mechanical Engineer I/II to develop innovative single-use fluid control assemblies and supporting instrumentation for next-generation bioprocessing and therapeutic technologies. This role will lead the mechanical design strategy for single-use consumables and associated instrumentation, ensuring robust closed-system performance aligned with GMP manufacturing requirements.

The engineer will own mechanical development across the full product lifecycle-from early concept and feasibility through detailed design, verification and validation, commercialization, and sustaining engineering-while collaborating closely with cross-functional teams to deliver highly reliable and manufacturable solutions.

Key Responsibilities

Mechanical Design & Development

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Lead mechanical design and development of integrated hardware and consumable subsystems for GMP manufacturing environments
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Create CAD models, detailed drawings, specifications, BOMs, and ECO documentation
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Perform tolerance analyses and FEA
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Drive prototype builds, engineering testing, and root-cause/failure analysis
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Optimize designs for manufacturability, reliability, and cost efficiency

Bioprocessing Systems

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Design and develop single-use consumables and fluid handling systems supporting sterile closed-system processing
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Develop fluid circuits and integrated thermal/fluid control components including pumps, valves, sensors, heaters, and manifolds
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Apply biocompatible material selection and sound mechanical design principles
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Support system-level testing for functionality, performance, and robustness

Verification & Validation

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Develop and execute verification and validation test strategies
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Document test methods, protocols, and results
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Support transfer of products into manufacturing
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Generate and maintain Design History File (DHF) documentation

Collaboration & Process Improvement

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Collaborate cross-functionally with engineering, quality, manufacturing, and supplier teams
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Provide technical updates to leadership and mentor junior engineers
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Develop SOPs and work instructions
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Support continuous improvement initiatives and adherence to engineering best practices

Qualifications

Education

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Bachelor's degree in Mechanical Engineering required
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Master's degree preferred

Experience

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5+ years of experience in mechanical design within medical device, life sciences, bioprocessing, pharmaceutical, or other regulated environments
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10+ years preferred for Senior Level II candidates

Technical Expertise

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Experience designing single-use consumables and fluid control assemblies for sterile or bioprocessing applications
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Strong understanding of fluid handling systems including tubing-based flow paths, pumps, valves, manifolds, and pressure-driven systems
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Experience with fluid sensing technologies such as pressure, bubble, and liquid detection
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Experience designing mechanical interfaces, sealing solutions, and disposable-to-instrument connections
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Familiarity with DFx methodologies including design for manufacturability, assembly, reliability, and cost
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Proficiency with SolidWorks; PDM experience preferred
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Working knowledge of FEA tools and statistical analysis methodologies preferred

Manufacturing & Compliance

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Experience supporting GMP manufacturing and cleanroom-compatible product development
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Understanding of ISO 13485, GMP, ISO 14971, ISO 10993, and related quality standards
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Experience with validation testing, protocol development, and outsourced testing management preferred

Additional Skills

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Hands-on prototyping and fabrication experience including injection molding, CNC machining, 3D printing, sheet metal, and automated assembly processes
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Strong communication and cross-functional collaboration skills
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Ability to manage multiple priorities in a fast-paced environment