Senior Medical Device Process Development & Transfer Lead

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

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.