RA Capital

Magenta Medical is a Class III medical device company that develops the smallest and most powerful heart pump in the world. As a commercial manufacturing and scale-up approach, we're expanding our Operations and Engineering teams. Join us to help build the foundation for success!We are seeking a talented Mechanical/Biomedical/Material Engineer to join our Engineering team, leading multiple processes and a complex product through the transition to manufacturability.

Responsibilities

• Lead New Product Introduction (NPI) processes, including transfer from R&D to production.
• Optimize manufacturing processes, including the design and development of production equipment and jigs.
• Writing manufacturing documentation
• Provide production floor support through effective problem-solving and root cause analysis.
• Collaborate with external suppliers and subcontractors to ensure quality, efficiency, and compliance.
• Lead equipment and process qualifications (IQ, OQ, PQ)
• Lead and implement engineering changes (ECOs) to improve design and manufacturing outcomes
• Writing test protocols and reports.



Team Leader

• B.Sc. in Mechanical, Biomedical, or Materials Engineering with a strong mechanical orientation.
• 3-5 years of experience (medical device industry- an advantage).
• Acquittance quality assurance and regulatory standards.
• Proven hands-on expertise in process development.
• Proficiency in SolidWorks (and PDM).
• Analytical skills.
• Good written/verbal communication skills.
• Strong interpersonal skills with the ability to collaborate effectively across multidisciplinary teams