Principal Process Development Engineer

Magnendo Corp.; Newton (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Magnendo Corp. is seeking a Principal Process Development Engineer to lead the supplier-facing process development and manufacturing-transfer strategy for our magnetically deflectable guidewires and polymer manufacturing supply chain.

You will translate prototype process learning into supplier-ready specifications, and drive the transfer from prototype-scale through pilot production to commercial readiness, partnering with QA and external suppliers to mitigate risks.

Qualifications

• Minimum 10+ years in medical-device process development, supplier development, or related manufacturing field.
• Experience in outsourcing, transfer to suppliers, and regulated transfer of interventional devices (neurovascular preferred).
• Familiarity with ISO 13485, 21 CFR Part 820, ISO 14971, validation, sterilization, and biocompatibility.

Responsibilities

• Lead supplier-facing process development and manufacturing-transfer strategy for Magnendo’s polymer and guidewire manufacturing supply chain.
• Translate prototype process learnings into supplier-ready specifications, process specs, inspection methods, and transfer packages.
• Translate R&D formulations and early process knowledge into scalable supplier-enabled manufacturing paths.
• Lead the transfer from prototype-scale through pilot production, design transfer, and commercial readiness.
• Identify, evaluate, qualify, and manage external suppliers and contract manufacturers across polymers, coatings, sterilization, and analytical labs.
• Define supplier requirements, control plans, TMV/IQ/OQ/PQ, lot-release testing, and process capability targets.
• Mitigate risks and drive issues to resolution with internal teams and external partners.

Skills

Medical-device process development

Supplier development

Manufacturing engineering

Polymer processing

Catheter/guidewire manufacturing

Regulatory transfer

DOE / design of experiments

Process validation

Education

Bachelor’s degree in Polymer Science, Materials Science, Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field

Job description

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 forMagnendo’sproprietarymagnetically deflectable guidewiresandmanufacturing supply chain.

You Will:

• Lead the supplier-facing process development and manufacturing-transfer strategy forMagnendo’sproprietary polymer andguidewire manufacturing supply chain.
• Translateprototype-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 forMagnendo’sproprietary magneticpolymersand steerable guidewires
• Lead the process-development and manufacturing-transferstrategy,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

You Are:

• An experienced engineer with10+ 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, Operational Excellence, Lean product and process development, design of experiments (DOE), root-cause analysis, or equivalent structured process-improvement methodologies
• Experienced applying process-development and validation tools, including process characterization, pFMEA, control plans, TMV, IQ/OQ/PQ, process capability, incoming inspection, in-process inspection, and lot-release testing
• Adaptable and comfortable contributing as the primary process-development and manufacturing-transfer expert within a small, fast-moving team, while recognizing when specialized external support is needed
• An effective collaborator and communicator who thrives in an environment built on teamwork, transparency, accountability, and shared problem-solving
• Bachelor’s degree in Polymer Science, Materials Science, Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field

Bonus Points:

• Advanceddegreein Polymer Science, Materials Science, Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field
• Experience with additive-loaded, radiopaque, lubricious, magnetic, or otherwise functionalized polymer compounds
• Experience developing polyurethane compoundscontainingmicron-scale powders or functional additives
• Experience with neurovascular guidewires, catheters, or other highly specialized interventional devices
• Experienceestablishingor scaling a supplier network for an early-stage medical-device company