Process Quality Engineer
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.
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.
Company at a glance
Magenta is developing miniaturized catheter-mounted axial flow-pumps for mechanical circulatory support indications, based on Magenta’s core technology of self-expanding impellers and pump heads.
Our percutaneous Left Ventricular Assist Device (pLVAD) is a next-generation low-profile arterial pump, intended for temporary support of patients undergoing high-risk coronary interventions and the treatment of patients admitted with cardiogenic shock.
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