Mechanical/Manufacturing Engineer - Biotech Ops

Helios Cardio; Natick (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Helios Cardio in Natick, MA is seeking an experienced Mechanical/Manufacturing Engineer to support our manufacturing operations, equipment uptime, and production infrastructure. You will build, maintain, and source key production equipment, and work with cross-functional teams to improve reliability in cleanroom and general environments.

The role requires a Bachelor's in Mechanical/Manufacturing Engineering and 5+ years in manufacturing, with preference for experience in regulated settings and

Qualifications

• Bachelor’s degree in Mechanical or Manufacturing Engineering or closely related field.
• 5+ years of hands-on engineering experience in manufacturing, equipment maintenance, and process development.
• Experience in regulated environments with QMS and IQ/OQ/PQ validation is preferred.

Responsibilities

• Build, maintain, troubleshoot, and source key production equipment to ensure continuous manufacturing operations.
• Provide direct engineering support for a large industrial lyophilizer.
• Develop and optimize custom mechanical cutting processes for raw materials and components.
• Consult on design and testing of custom mechanical equipment by vendors.
• Manage and oversee general mechanical equipment including RO/DI water systems, chillers, and pumps.

Skills

CAD drawings

Equipment maintenance

Downstream process development

Production simulations

Lyophilization systems

Education

Bachelor's degree in Mechanical Engineering

Tools

CNC

Job description

Helios Cardio in Natick, MA is seeking an experienced Mechanical/Manufacturing Engineer to support our manufacturing operations, equipment uptime, and production infrastructure. You will build, maintain, and source key production equipment, and work with cross-functional teams to improve reliability in cleanroom and general environments.

The role requires a Bachelor's in Mechanical/Manufacturing Engineering and 5+ years in manufacturing, with preference for experience in regulated settings and