Senior Process Dev Engineer, Medical Devices & Transfer

Magnendo Corp.; Newton (MA); On-site; USD 140,000 - 200,000; Full time

Job summary

Magnendo is advancing robotic technology for endovascular procedures. We seek an experienced engineer to lead supplier-facing process development and manufacturing-transfer strategies for proprietary polymer and guidewire manufacturing, translating R&D learning into supplier-ready packages from prototype through transfer.

With 10+ years in medical-device manufacturing, you will drive scalable, compliant processes, collaborate with QA, and manage external suppliers to ensure robust,

Qualifications

• 10+ years in medical-device process development or related interventional-device manufacturing.
• Experience outsourcing and regulated transfer of interventional medical devices.
• Translating polymer-based technologies from R&D to supplier-controlled manufacturing.
• Proven success in transferring devices into manufacturing and through FDA-clearance/approval.

Responsibilities

• Lead supplier-facing process development and manufacturing-transfer strategy for Magnendo’s polymer and guidewire supply chain.
• Translate prototype-process learning into supplier-ready specifications and transfer packages.
• Develop scalable manufacturing paths for magnetic polymers and steerable guidewires.

Skills

Process development

Supplier development

Manufacturing engineering

Polymer processing

Catheter/guidewire

FDA/ISO 13485

DOE

Project leadership

Education

Bachelor's degree in Polymer Science

Job description

Magnendo is advancing robotic technology for endovascular procedures. We seek an experienced engineer to lead supplier-facing process development and manufacturing-transfer strategies for proprietary polymer and guidewire manufacturing, translating R&D learning into supplier-ready packages from prototype through transfer.

With 10+ years in medical-device manufacturing, you will drive scalable, compliant processes, collaborate with QA, and manage external suppliers to ensure robust,