Senior Engineer I/II, Mechanical

Description:

MaxCyte is seeking a Senior Mechanical Engineer I/II to develop innovative single-use fluid control assemblies and supporting instrumentation for next-generation life sciences technologies. In this role, you will define and lead the mechanical design strategy for single-use consumables and associated instrumentation ensuring robust closed-system performance aligned with GMP manufacturing requirements. You will own the mechanical development across the full product lifecyclefrom early concept and feasibility through detailed design, verification and validation, commercialization, and sustaining engineeringwhile collaborating closely with other engineers and cross-functional teams to integrate seamlessly with other subsystems. Together, you will deliver solutions that meet the highest standards for performance, reliability, and manufacturability.

Job Responsibilities:

• Mechanical Design & Development: Lead mechanical design and development of integrated hardware and consumable subsystems for GMP manufacturing. Create CAD models & detailed drawings, specifications, BOMs, and ECOs. Perform tolerance analyses and FEA. Drive prototype builds, engineering testing, and failure/root-cause analysis. Evaluate and optimize designs for manufacturability with cost consideration.
• Bioprocessing Systems: Design and develop bioprocess consumables and systems that support closed, sterile, single-use processing in GMP manufacturing environments, including fluid circuits, interfaces, and integrated fluid and thermal control components such as pumps, valves, heaters, and sensors. Apply biocompatible material selection and mechanical design principles to ensure reliable performance while meeting biological process requirements. Support system-level testing for functionality, performance, and robustness.
• Verification & Validation: Develop and execute test strategies. Document test methods and verification results. Ensure designs are effectively and efficiently transferred to production. Generate documentation for Design History Files (DHF).
• Collaboration: Collaborate with other technical disciplines and quality teams. Engage and manager suppliers. Provide updates to management. Mentor and provide guidance to more junior engineers.
• Ensure Process Excellence: Champion adherence to engineering processes, safety requirements, and industry best practices. Develop Work Instructions and SOPs.

• Education: B.S. in Mechanical Engineering required; M.S. preferred.
• Experience: 5+ years of relevant experience in mechanical design in life science consumable, medical device, pharma, bioprocess components, or other regulated product development environments. 10+ years for Level II.
• Single Use Consumables: Direct experience designing single-use consumables and fluid control assemblies for cell therapy, gene therapy, bioprocessing, or sterile fluid handling systems. Experience with scaling up and high-volume manufacturing.
• Bioprocessing Technology: Experience designing bioprocessing technologies such bioreactors, gas exchange, filtration, centrifugation, cell isolation, purification, process analytics, etc.
• Fluid Systems: Strong understanding of fluid handling and fluid control systems, including tubing-based flow paths, pressure-driven flow, pumping, valving, and manifolds,. Experience integrating fluid sensing including bubble detection, pressure & liquid sensing, etc. Experience with FEA preferred (e.g., COMSOL).
• GMP Manufacturing Experience: Experience designing for GMP manufacturing environments, including cleanroom-compatible use, contamination control, and sterile closed-system processing. Strong knowledge of materials used in GMP manufacturing systems.
• Mechanical Expertise: Experience designing complex mechanical systems, subsystems, and components. Experience designing fluid interfaces and sealing solutions including rotating fluid connections, dynamic seals, face seals, gaskets, and disposable-to-instrument mating mechanisms.
• Design For X: Experience with DFx including manufacturing, assembly, reliability, usability, cost, etc. Experience with tolerance analysis.
• CAD: Proficient in SolidWorks. Experience with SolidWorks PDM preferred.
• Quality by Design: Experience with QbD principles, Design for Six Sigma (DFSS), Critical Parameters Design and Management (CPD&M) or similar. Working knowledge of Minitab for statistical analysis and Design of Experiments (DOE) preferred.
• Hands-On Skills: Skilled in prototyping. Working knowledge of fabrication and assembly methods such as plastic injection molding, 3D printing, CNC machining, sheet metal forming, semi-automated & automated assembly, adhesives, conversion of films and foils, etc. Working knowledge of metrology tools.
• Compliance: Strong knowledge of Design Control (ISO 13485) and GMP compliance for cell therapy manufacturing environments. Familiar with ISO 9001, ISO 10993, ISO14971 and other relevant international safety and quality standards.
• Verification & Validation: Experience writing protocols, executing tests, overseeing outsourced testing, and writing reports. Knowledge of extractables/leachable, sterilization methods, particulate control preferred.
• Collaboration: Strong interpersonal skills with a track record of cross-functional collaboration, problem solving, and driving technical alignment.
• Communication: Excellent written and verbal communication skills.
• Travel: Ability to travel 10-15% domestically.

Depending on experience the annual salary for this role is $115,000-$140,000. MaxCyte also offers a comprehensive benefits package including health, dental, vision, life, and disability insurance and generous time off.

MaxCyte is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Compensation details: 115000-140000 Yearly Salary

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