Magenta Medical develops the Elevate™ percutaneous LVAD for temporary mechanical circulatory support during high-risk coronary interventions and cardiogenic shock. Backed by NEA.
About the role
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.
What they're looking for
- 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
More about this role
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.
- 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.
-...
Browse similar: Startup jobs · Remote jobs