Sr. Mechanical Engineer

Senior Mechanical Engineer I/II – Job Description Overview We are seeking a Senior Mechanical Engineer I/II to design and develop innovative single-use fluid control assemblies and supporting instrumentation for advanced life sciences applications. This role involves leading the mechanical design strategy for consumables and associated hardware, ensuring reliable performance in regulated manufacturing environments. The position spans the full product lifecycle, including concept development, detailed design, testing, validation, commercialization, and sustaining engineering. You will collaborate cross-functionally to deliver high-performance, manufacturable solutions that meet strict regulatory and quality standards. Key Responsibilities Mechanical Design & Development Lead the design and development of integrated hardware systems and consumable components for regulated manufacturing environments Create CAD models, technical drawings, specifications, bills of materials (BOMs), and engineering change orders (ECOs) Perform tolerance analysis, FEA, and design optimization for manufacturability and cost Drive prototyping, engineering testing, and root cause analysis for design improvements Bioprocessing Systems Design single-use consumables and systems supporting sterile, closed-process manufacturing Develop fluid circuits, interfaces, and integrated fluid and thermal control components (e.g., pumps, valves, heaters, sensors) Select biocompatible materials and ensure designs meet biological and performance requirements Support system-level testing for functionality, robustness, and reliability Verification & Validation Develop and execute test plans and validation strategies Document test methods, results, and conclusions Support transfer of designs into production Work with cross-functional teams including engineering, quality, and manufacturing Engage with and manage suppliers Provide updates to stakeholders and leadership Mentor junior engineers and provide technical guidance Process Excellence Ensure adherence to engineering processes, safety standards, and industry best practices Develop work instructions and standard operating procedures (SOPs) Qualifications Education Bachelor’s degree in Mechanical Engineering required Experience 5+ years of experience in mechanical design within regulated industries such as medical devices, life sciences, pharmaceuticals, or bioprocessing (10+ years for Level II) Experience designing single-use consumables and fluid control systems Background in scaling products for high-volume manufacturing Technical Expertise Strong understanding of fluid handling systems, including tubing-based flow paths, pumps, valves, and manifolds Experience integrating fluid sensing technologies (e.g., pressure, bubble, or liquid sensing) Knowledge of bioprocess technologies such as filtration, gas exchange, cell processing, or purification Experience with mechanical system design, sealing solutions, and fluid interfaces Design & Tools Proficiency in CAD software (SolidWorks preferred) Experience with FEA and tolerance analysis Familiarity with design methodologies such as DFx (Design for Manufacturing, Assembly, Reliability, Cost, etc.) Manufacturing & Hands-On Skills Experience with prototyping and fabrication methods including injection molding, CNC machining, 3D printing, and assembly processes Working knowledge of metrology and testing equipment Regulatory & Quality Experience with GMP environments and cleanroom-compatible design Knowledge of design controls and applicable standards (e.g., ISO 13485, ISO 9001) Familiarity with validation processes, risk management, and documentation practices Additional Skills Strong problem-solving and analytical skills Proven ability to collaborate across teams Other Requirements Ability to travel domestically (approximately 10–15%) #J-18808-Ljbffr