Job Description
Location: Natick, MA
Qualifications:
- 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.
Responsibilities:
- 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 careers@helioscardio.com.