Job Description

Helios Cardio logoLocation: Natick, MA


  • Bachelor’s Science/Engineering (Required)
  • Minimum 3 years of medical device manufacturing experience
  • Knowledge of medical device quality and manufacturing validations
  • Experience with Current Good Manufacturing Practice (cGMP) and ISO 13485
  • Experience working under a medical device Quality Management System (QMS)

Company Background:

Helios Cardio Inc. is a Massachusetts based company producing next generation medical devices for
cardiac surgery with the first products based on processing of animal tissues. This is a dynamic and high
growth opportunity position at an early phase organization about to take-off and join an experienced
management team with proven success in this space.

Job Description:

Helios Cardio is seeking a Manufacturing and Quality Engineer with experience designing, writing, and
executing manufacturing processes for medical devices meeting US (FDA) and international (EU / MDR)
quality standards. A qualified candidate will be suited to operating with a high degree of independence
in the dynamic environment of a growing start-up and therefore capable of leading and completing all
aspects of process design, validation, and hands-on support of manufacturing. An ideal candidate is
capable of both generating and operating all aspects of manufacturing ultimately leading to training and
managing future personnel as the growth trajectory requires.


  • Design, write, and implement process and workflow procedures, either internally or with contract manufacturing partners
  • Design, write, and complete manufacturing process validations, either internally or with contract manufacturing partners
  • Assist with developing machine specifications for new equipment and modify equipment for effective process flow.
  • Design, write, and complete manufacturing equipment validations (IQ/OQ/PQ)
  • Train newly hired or contract manufacturing personnel on production procedures, safety, and quality requirements
  • Leads and/or supports DCRs; CAPAs, and NCs related to the manufacturing process.
  • Creates, updates, and maintains BOMs, pFMEAs and DMRs.
  • Play a lead role in design reviews from a Manufacturing Engineering standpoint.
  • Work with Quality to ensure that all processes are in compliance standards and requirements.

Physical Requirements:

  • Must be able to lift up to 50 pounds at times

Interested candidates should submit their resume together with a cover letter to