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 * Lead mechanical design and development of integrated hardware and consumable subsystems for GMP manufacturing environments * Create CAD models, detailed drawings, specifications, BOMs, and ECO documentation * Perform tolerance analyses and FEA * Drive prototype builds, engineering testing, and root-cause/failure analysis * Optimize designs for manufacturability, reliability, and cost efficiency Bioprocessing Systems * Design and develop single-use consumables and fluid handling systems supporting sterile closed-system processing * Develop fluid circuits and integrated thermal/fluid control components including pumps, valves, sensors, heaters, and manifolds * Apply biocompatible material selection and sound mechanical design principles * Support system-level testing for functionality, performance, and robustness Verification & Validation * Develop and execute verification and validation test strategies * Document test methods, protocols, and results * Support transfer of products into manufacturing * Generate and maintain Design History File (DHF) documentation Collaboration & Process Improvement * Collaborate cross-functionally with engineering, quality, manufacturing, and supplier teams * Provide technical updates to leadership and mentor junior engineers * Develop SOPs and work instructions * Support continuous improvement initiatives and adherence to engineering best practices Qualifications Education * Bachelor's degree in Mechanical Engineering required * Master's degree preferred Experience * 5+ years of experience in mechanical design within medical device, life sciences, bioprocessing, pharmaceutical, or other regulated environments * 10+ years preferred for Senior Level II candidates Technical Expertise * Experience designing single-use consumables and fluid control assemblies for sterile or bioprocessing applications * Strong understanding of fluid handling systems including tubing-based flow paths, pumps, valves, manifolds, and pressure-driven systems * Experience with fluid sensing technologies such as pressure, bubble, and liquid detection * Experience designing mechanical interfaces, sealing solutions, and disposable-to-instrument connections * Familiarity with DFx methodologies including design for manufacturability, assembly, reliability, and cost * Proficiency with SolidWorks; PDM experience preferred * Working knowledge of FEA tools and statistical analysis methodologies preferred Manufacturing & Compliance * Experience supporting GMP manufacturing and cleanroom-compatible product development * Understanding of ISO 13485, GMP, ISO 14971, ISO 10993, and related quality standards * Experience with validation testing, protocol development, and outsourced testing management preferred Additional Skills * Hands-on prototyping and fabrication experience including injection molding, CNC machining, 3D printing, sheet metal, and automated assembly processes * Strong communication and cross-functional collaboration skills * Ability to manage multiple priorities in a fast-paced environment