Process Validation Engineer

About the Company

Magenta Medical is a Class III medical device company that develops the smallest and most powerful heart pump in the world. With commercial manufacturing and scale-up on the horizon, we're expanding our Operations and Engineering teams - join us to help build the foundation for success!

About the Role

We are hiring an experienced Process Validation Engineer.

As a Process Validation Engineer, you will be involved in validating manufacturing processes for the company’s flagship project. The role encompasses all relevant aspects required for validating current production processes, as well as participating in the development of new production processes, including Tech Transfer, PFMEA, PVMP, IQ, OQ, and PQ.

Collaboration is key in this position, as you will work closely with cross-functional teams, including Engineering, Quality, and Operations.

Responsibilities

• Validate manufacturing processes.
• Participate in the development of new production processes, including Tech Transfer, PFMEA, PVMP, IQ, OQ, PQ, etc.
• Collaborate with cross-functional teams.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field - must.
• 3-5 years of experience in product lifecycle development in the Medical Device industry - must.
• Experience with complex mechanical/material production processes (advantageous).
• Familiarity with Process Validation Master Protocols (PVMP).
• Knowledge of risk assessment methodologies, including DFMEA and PFMEA.
• Experience with Test Method Validation.
• Proficiency in Design of Experiments (DOE) analyses.
• Experience in writing protocols and reports.

Required Skills

• Proficiency in CAD software (SolidWorks).
• Experience with data analysis/statistical software (JMP or MiniTab).
• Strong problem-solving, analytical, and troubleshooting skills.
• Ability to collaborate effectively in cross-functional teams.
• Strong written and verbal communication skills in English.
• Excellent interpersonal skills.

Why join now?

• Be part of a startup atmosphere with the ambition for a commercial launch.
• Play a pivotal role in building our manufacturing systems and processes from the ground up.
• Work in a cross-functional team that values innovation, ownership, and impact.