Build a career in biomanufacturing
No four-year degree required for many of our roles. We’ll train you.
Our team spans a wide range of educational backgrounds, from high school diplomas to PhDs. Many of our manufacturing and quality roles do not require a four-year degree. We provide structured, on-the-job training in GMP manufacturing, cleanroom practice and quality systems — skills that carry across the Massachusetts biomanufacturing sector.
Because we make commercial and clinical products while developing our own pipeline, our people gain experience across the full product lifecycle, with room to grow across functions.
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- Apply for Mechanical/Manufacturing Engineer for Biomedical Devices
Mechanical/Manufacturing Engineer for Biomedical Devices
We are seeking a Mechanical/Manufacturing Engineer to support our manufacturing operations and production infrastructure.
View details for Mechanical/Manufacturing Engineer for Biomedical Devices
Role Overview
We are seeking a Mechanical/Manufacturing Engineer to support our manufacturing operations and production infrastructure. In this role, you will play a hands-on role in constructing, maintaining, and sourcing key production equipment—including custom CNC machines and precision cutting machines—while scaling up and optimizing cutting processes. Working closely with cross-functional teams, you will ensure seamless equipment uptime, process reliability, and operational efficiency across 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.
- Design, build, and optimize custom mechanical cutting processes, CNC machinery, and precision cutting machines for raw materials and finished components, focusing on scaling up production.
- 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: 2+ years of relevant hands-on engineering experience in manufacturing, equipment maintenance, prototyping, or custom machinery development. Experience in regulated environments (medical devices, pharmaceuticals, aerospace, or similar) and familiarity with Quality Management Systems (QMS) is preferred.
- Technical Skills: Proficiency in CAD, prototyping, custom fabrication, precision cutting machines, and CNC machining. Hands-on experience with equipment maintenance, process scale-up, custom cutting operations, machine shop fabrication/making, and automation is highly valued.
- 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 their legacy of excellence. We offer a collaborative and inclusive work environment, competitive compensation, and opportunities for professional growth.
How to Apply:
Submit your resume and a cover letter detailing your relevant experience and achievements by clicking the application link below.
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.
Helios Biomedical is an equal opportunity employer.