Principal Process Development Engineer

Every minute matters in stroke treatment. Magnendo is developing robotic technology to make life-saving endovascular procedures faster, safer, and more accessible. By combining advanced robotics, magnetic navigation, and intelligent software, we are tackling one of the most technically demanding challenges in healthcare while aiming to expand access to advanced stroke care for patients around the world. Join us in shaping the future of endovascular intervention.

We are looking for a Principal Process Development Engineer to lead the supplier-facing process development and manufacturing-transfer strategy for Magnendo’sproprietarymagnetically deflectable guidewiresandmanufacturing supply chain.

Lead the supplier-facing process development and manufacturing-transfer strategy for Magnendo’sproprietary polymer andguidewire manufacturing supply chain.

Translate prototype-process learning into supplier-ready material specifications, process specifications, inspection methods, test methods, and manufacturing-transfer packages

Translate R&D formulations, prototype builds, and early process knowledge into a robust, scalable, supplier-enabled manufacturing path for Magnendo’sproprietary magneticpolymersand steerable guide wires

Lead the process-development and manufacturing-transfer strategy,from prototype-scale development through pilot production, design transfer, and commercial manufacturing readiness

Identify, evaluate, select, qualify, and develop the external suppliers, including compounders, additive-processing specialists, extrusion houses, catheter and guidewire contract manufacturers, coating suppliers, sterilization vendors, analytical laboratories, and specialty wire andcomponentsuppliers

Work with the QA team to define supplier requirements, process controls, validation strategies, and transfer plans, includingTMV,IQ/OQ/PQ,control plans, incoming and in-process inspection, lot-release testing, and process-capability targets

Anticipate technical, quality, supplier, and scale-up risks; develop practical alternatives and mitigation plans; and drive issues to resolution before they become program risks

An experienced engineer with
10+ years of experience in medical-device process development, supplier development, manufacturing engineering, polymer processing, catheter or guidewire manufacturing, or related interventional-device manufacturing

Experienced in the development, outsourcing, manufacturing, and regulated transfer of interventional medical devices, preferably neurovascular devices

Experienced translating novel polymer-based technologies from R&D prototypes into supplier-controlled manufacturing processes

Successful in transferring interventional medical devices, novel materials, polymer-based components, catheter or guidewire components, or other complex medical-device technologies into manufacturing and through FDA-cleared or FDA-approved product development

Proactive, creative, and practical, with the ability toanticipateproblems, challenge assumptions, develop alternatives, and drive solutions across internal teams and external partners

Knowledgeable in medical-device manufacturing and design controls, including ISO 13485, 21 CFR Part 820, ISO 14971, verification and validation, sterilization, biocompatibility, and regulated manufacturing documentation

Experienced with medical-gradethermoplasticpolymersand knowledgeable in polymer compounding, additive treatment and dispersion, drying and material handling, extrusion, molding, bonding, and coating compatibility

Experienced selecting, qualifying, developing, and managing external suppliers or contract manufacturers for medical-device development and manufacturing programs

Completely familiar with, and able to deploy,…