Mechanical/Manufacturing Engineer for Biomedical Devices

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

Job Type: Full-Time, 5+ Years Experience

Location: Natick, MA

Role Overview

We are seeking an experienced Mechanical/Manufacturing Engineer to support our manufacturing operations and production infrastructure. In this role, you will be responsible for building, maintaining, and sourcing key production equipment, supporting custom manufacturing processes, and overseeing general facility systems. Working closely with cross-functional teams, you will ensure seamless equipment uptime, process reliability, and operational efficiency across controlled cleanroom and general production environments.

Key Responsibilities

Equipment & Production Support

• 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.

Work Environment

• 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).

Required Qualifications & Experience

• Education: Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a closely related engineering discipline.
• 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.
• Technical Skills: 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.
• Mindset: A hands-on problem solver with a dedication to maintaining high equipment reliability and production quality.

Desired Attributes

• Adaptability: Highly versatile and comfortable navigating the shifting priorities and dynamic environment of an innovative biotech company.
• Attention to Detail: Meticulous organizational and documentation skills, understanding the critical nature of traceability in a regulated medical device development environment.
• Collaboration: A proactive team player who communicates clearly and is eager to learn.
• Agile Execution: Capable of maintaining high standards of quality while working with a sense of urgency to meet tight project timelines in a fast-paced, dynamic environment.

Why Join Us?

Join a team dedicated to advancing healthcare through innovative technology. The biomedical devices of the Helios Group of companies have positively impacted patients’ lives for over two decades, and we are committed to maintaining its legacy of excellence. We offer a collaborative and inclusive work environment, competitive compensation, and opportunities for professional growth.

We are an equal-opportunity employer and encourage candidates of all backgrounds to apply. Candidates must be legally authorized to work in the United States without requiring future visa sponsorship (e.g., H-1B, F-1 OPT, etc.) at the time of hire or at any point in the future.

This role does not offer sponsorship for work authorization.