Process Quality Engineer

Magenta Med • Health Care • Bachelor's Degree • 2 days ago
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Salary
≈ $54k – $95k per year (Estimated)
Location
In office
Seniority
Junior · 2+ years exp
Employment
Full-Time

Confirmed on the employer's own hiring board on Sep 28, 2026. First seen by Alion on Sep 19, 2026.

Overview
Company
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Profile match

Magenta Med

Magenta Medical develops the Elevate™ percutaneous LVAD for temporary mechanical circulatory support during high-risk coronary interventions and cardiogenic shock.
magentamed.com • Health Care • Est. 2012

Description

We are seeking a Process Quality Engineer to join our growing QA team. This is an exciting opportunity to play a pivotal role in scaling the manufacturing of an innovative Class III medical device, driving process validation, continuous improvement, and implementing new processes from development through production.

Responsibilities

  • Lead and ensure the quality of NPI and manufacturing processes.
  • Lead and support Process Validation activities (IQ/OQ/PQ).
  • Review and approve work instructions, assembly instructions, manufacturing specifications, validation protocols, validation reports, as well as mechanical part and assembly drawings created in SolidWorks.
  • Support and manage Change Control processes.
  • Provide professional guidance to R&D, Engineering, and Manufacturing teams on quality requirements, NPI, and manufacturing processes.
  • Collaborate closely with R&D, Engineering, and Manufacturing teams to implement process changes, drive continuous improvements, and ensure product quality.
  • Identify, lead, and implement continuous improvements in NPI and manufacturing processes while ensuring compliance with quality requirements, ISO 13485 standards, and FDA regulatory requirements.
  • Provide QA oversight and support for Design Transfer / NPI activities, ensuring a smooth and compliant transfer of products from R&D to manufacturing.

Reports to

QA Manager

Requirements

  • B.Sc. in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or a related engineering discipline.
  • Strong experience in mechanical product development or manufacturing.
  • Minimum of 2-4 years of experience as an engineer in the Medical Device industry.
  • Hands-on experience with Process Validation (IQ/OQ/PQ) and Design Transfer / NPI activities.
  • Experience with Change Control processes.
  • Experience working with mechanical CAD drawings.
  • Ability to independently lead projects and drive cross-functional processes to completion.
  • Strong self-learning capability.
  • Excellent interpersonal and communication skills.
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