3 jobs found

Description: MaxCyte is seeking a Mechanical Engineer to support the development of next-generation life sciences technologies. In this role, you will contribute to the mechanical design and development of single-use consumables and associated instruments that enable cell engineering workflows. Working under the guidance of senior engineers and cross-functional teams, you will assist with mechanical design activities throughout the product lifecycle-from early concept and prototyping through testing, verification, manufacture, and commercialization. This is an excellent opportunity to build hands-on engineering experience while contributing to innovative, high-impact medical and life sciences products. Job Responsibilities: Mechanical Design & Development: Support the mechanical design and development of hardware and consumable subsystems used in cell & gene therapy instrumentation. Robust Design: Apply DFx and Design for Six Sigma (DFSS) to develop robust products that meet user needs. Perform and document basic tolerance analysis & FEA. Design & Document: Create and update CAD models, detailed drawings, and basic design documentation. Prepare design specifications, bills of materials (BOMs), and engineering change orders (ECOs). Prototype and Test: Build prototypes, perform engineering tests, collect data, troubleshoot, optimize, and iterate designs. Design and conduct statistical Design of Experiments (DOEs). Verification & Validation: Write and execute test protocols. Document results in engineering reports. Ensure designs are effectively and efficiently transferred to production. Generate documentation for Design History Files (DHF). Support Manufacturing: Work with suppliers. Develop assembly processes. Optimize design for manufacturing and assembly. Participate in failure investigations and root cause analysis (RCA). Collaboration & Communication: Work under guidance of more senior engineers, collaborate with engineers and scientists in other disciplines and quality teams. Actively participate in scrums and stand-up meetings. Provide regular updates to management. Ensure Process Excellence: Follow established engineering processes, design controls, and CAD/documentation standards. Adhere to quality and safety standards. Requirements: Education: B.S. in Mechanical Engineering required; M.S. preferred. Experience: 0-3 years of relevant experience in mechanical design. Experience in life science, medical device, or other regulated product development environments preferred. Mechanical Expertise: Experience designing mechanical systems, subsystems, and components. Experience with mechanisms and complex assemblies preferred. Electromechanical experience a plus. Design For X: Experience with DFx including manufacturing, assembly, reliability, usability, cost, etc. Experience with tolerance analysis. CAD: Highly proficient in SolidWorks. Experience with SolidWorks Simulation and PDM preferred. Quality by Design: Experience with 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 and using hand tools. Working knowledge of fabrication and assembly methods such as 3D printing, CNC machining, sheet metal forming, plastic injection molding, manual assembly, semi-automated & automated assembly, adhesives, snaps, fasteners, etc. Working knowledge of metrology tools. Test & Optimize: Experience designing and executing engineering tests. Experience with troubleshooting and root cause analysis (RCA) preferred. Design Control: Experience with Design Control (ISO 13485) and GMP compliance for medical device or pharma preferred. Familiar with ISO 9001 & ISO 14971 and other relevant international safety and quality standards a plus. Collaboration: Strong interpersonal skills with a track record of cross-functional collaboration & problem solving. Communication: Excellent written and verbal communication skills. Travel: Ability to travel 10-15% domestically. Depending on experience the annual salary for this role is $80,000-$92,000. 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: 0 Yearly Salary PI7317ec5aedc1-2577

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 lifecycle-from early concept and feasibility through detailed design, verification and validation, commercialization, and sustaining engineering-while 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. Requirements: 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: 00 Yearly Salary PIbfb428c5-

Position Summary: The Staff Mechanical Engineer serves as a senior technical leader responsible for driving complex mechanical system designs from concept through production. This role leads large-scale engineering projects with a strong emphasis on advancing existing product platforms and delivering configure to order solutions. The engineer creates comprehensive engineering documentation-including advanced plumbing schematics, 3D SolidWorks models, analyses, test procedures, and root-cause investigations-while ensuring the highest standards of quality, clarity, and technical rigor. In addition to delivering individual project work, the Staff Mechanical Engineer provides technical leadership across the engineering team, mentoring junior engineers, establishing design standards, and promoting best practices in mechanical design, DFx principles, and project management. The position requires regular hands on collaboration with manufacturing engineers on the shop floor to ensure successful build and integration of equipment. The ideal candidate brings deep expertise in mechanical engineering, extensive experience in advanced system design and analysis, strong interpersonal and communication skills, and a proven ability to manage multiple complex projects simultaneously. This role contributes significantly to product excellence and organizational capability by modeling professionalism, accountability, and technical excellence Essential Job Duties and Responsibilities: Create all engineering documents including advanced plumbing system schematics, Bill of Materials, 3D Solidworks solid models, simulations and analyses, test procedures, root cause analyses, etc. Lead large and complex engineering design projects with particular focus on building on existing product platforms and configure-to-order jobs Design for simplicity leveraging robust project management, quality and product development methods and best practices scaled appropriately to each project Communicate clearly with internal and external team members globally Create high quality easily readable documents for internal and external readers Handle multiple projects at a time while also overseeing projects run by more junior engineers Exhibit strong presence on the shop floor working with manufacturing engineers during design and manufacture of equipment Demonstrate exceptional professionalism and mechanical aptitude Approve and initialize all design standards Provide mentorship and training to design team members Qualifications (Experience, Skills, and Education) Bachelor's Degree in Mechanical Engineering and 15+ years' experience in mechanical systems design - 20+ years and / or Master's Degree preferred. Advanced knowledge of common engineering concepts, practices, procedures, and quality systems Expert-level knowledge of Solidworks 3D modeling practices High level of comfort with mechanical analyses of all types (thermal, structural, vibration, flow, etc. both by hand and by CAE) Thorough understanding of Design For X principles (DFx): manufacturability, test, reliability, serviceability, etc. Demonstrable experience as Project manager Excellent time management skills Excellent interpersonal skills At least 5 years team leadership and mentorship experience Ability to use Microsoft Office Applications 5 years' experience in Semi-conductor tool industry a plus Physical Requirements & Working Conditions: Standard office environment including work at a computer terminal. Work involves extended periods of sitting, occasional walking, stooping, bending, and lifting up to 50 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Other Requirements: Must be able to work in a highly functioning team environment. Display the highest levels of honesty, integrity, and professionalism. Take pride in your work and in the company. Communicate openly and strive for peak performance in daily tasks. Know and deliver the quality service RENA's customers have come to expect. This job description is intended to summarize the type and level of work performed by the incumbent and is not an exhaustive list of duties, responsibilities, and requirements. RENA North America is committed to Equal Opportunity (EEO) and to compliance with all Federal, State, and local laws that prohibit employment discrimination on any basis protected by law. Compensation details: 00 Yearly Salary PIff9e7258bab7-9101