Location: 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)
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.
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.
- Must be able to lift up to 50 pounds at times
Interested candidates should submit their resume together with a cover letter to firstname.lastname@example.org.