Project Engineer

Magenta Medical is a Class III medical device company developing the world’s smallest and most powerful heart pump. As part of our commercial manufacturing and scale-up strategy, we are expanding our Engineering teams. Join us to help build the foundation for success!

We are seeking a talented Biomedical / Materials Engineer to join our Engineering team and take ownership of material and coating-related processes, driving a complex product through the transition from development to scalable manufacturing.

Responsibilities

Lead material and coating-related activities within New Product Introduction (NPI), including transfer from R&D to manufacturing.
Optimize manufacturing processes, including material-related processes, and support the design and development of production equipment, fixtures, and jigs.
Prepare and maintain manufacturing documentation (e.g., work instructions, SOPs, BOMs).
Provide hands-on production floor support through effective troubleshooting, root cause analysis, and corrective actions.
Collaborate with external suppliers and subcontractors to ensure quality, efficiency, and regulatory compliance.
Lead equipment and process qualification activities (IQ/OQ/PQ).
Lead engineering change orders (ECOs) and drive implementation to improve design and manufacturing outcomes.
Write test protocols and generate technical reports to support verification and validation activitie

Requirements:

B.Sc. in Biomedical Engineering or Materials Engineering (Mechanical Engineering background/orientation is an advantage).
2–5 years of experience, preferably in the medical device industry (advantage).
Familiarity with quality assurance and regulatory standards (e.g., ISO 13485, GMP – if relevant).
Proven hands-on experience in process development and optimization.
Proficiency in SolidWorks (advantage).
Strong analytical and problem-solving skills.
Strong interpersonal skills and the ability to collaborate effectively across multidisciplinary teams.

Reports to:

Director of Engineering