Process Engineer- Medical Device

About the Company

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 approach, we're expanding our Operations and Engineering teams. Join us to help build the foundation for success!

We are seeking a Process Engineer to join our growing Engineering 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.

About the Role

This role involves leading process improvement initiatives for the company's flagship product.

Responsibilities

• Plan, execute, and document manufacturing process validation activities.
• Validate existing production processes to ensure compliance, consistency, and efficiency.
• Support the development, implementation, and transfer of new manufacturing processes into production.
• Collaborate closely with cross-functional teams, including R&D, Engineering, Quality, Production, and Operations.
• Identify opportunities to optimize processes to improve product quality, manufacturability, and operational efficiency.
• Ensure all process validation activities are performed in accordance with applicable quality and regulatory requirements.

Qualifications

• A bachelor’s degree in mechanical or biomedical engineering, or a related field.
• 3–5 years of experience in product lifecycle development within the medical device industry.
• 1–3 years of hands-on experience with process validation activities, including technology transfer, IQ, DOE, OQ, and PQ.
• Experience with complex mechanical or materials-based manufacturing processes.
• Hands-on experience operating manufacturing equipment and production tools, with proven expertise in manufacturing process optimization.
• Knowledge of risk assessment methodologies, including DFMEA and PFMEA.
• Familiarity with Process Validation Master Plans/Protocols (PVMP).
• Understanding of Test Method Validation processes.

Required Skills

• Proficiency in CAD software, particularly SolidWorks.
• Experience with data analysis and statistical software, such as JMP and/or Minitab.
• Strong problem-solving, analytical, and troubleshooting capabilities.
• Proven ability to work effectively within cross-functional teams.
• Strong written communication skills in English.
• Excellent interpersonal and relationship-building skills.