Hiring: Mechanical/Manufacturing Engineer for Biomedical Devices Company: Helios Cardio Location: Natick, MA Job Posted Time: 2026-09-10 13:11:58 Employment Type: Full-time Target Skills & Keywords : Agile, AutoCAD, CAD About the job Experience: •5+ years of relevant hands-on engineering experience in manufacturing, equipment maintenance, and mechanical process development. Experience in regulated environments (medical devices, pharmaceuticals, nuclear, aerospace, or similar) and familiarity with Quality Management Systems (QMS) and IQ/OQ/PQ validation processes is highly preferred. Required Skills: •Build, maintain, troubleshoot, and source key production equipment to ensure continuous manufacturing operations. •Provide direct engineering and operational support for a large industrial lyophilizer. •Develop and optimize custom mechanical cutting processes for raw materials and finished components. •Consult on design and testing of custom mechanical equipment by vendors. •Manage, maintain, and oversee general mechanical equipment, including RO/DI water systems, chillers, and pumps. •Perform engineering duties and maintenance activities across both cleanroom and non-cleanroom manufacturing environments. •Work in the area of BSL-1 biological materials and caustic chemicals (e.g., strong acids, strong bases). •Strong technical proficiency in mechanical design, troubleshooting, equipment maintenance, CAD drawings, and equipment documentation. Experience with automated systems, custom high precision cutting operations (e.g., CNC), downstream process development, production simulations, and/or lyophilization systems is a huge plus. Qualifications: •Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a closely related engineering discipline. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!