Neurovascular Manufacturing Engineer

Galaxy Therapeutics; Milpitas (CA); On-site; USD 115,000 - 125,000; Full time

Job summary

Galaxy Therapeutics is seeking a Neurovascular Manufacturing Engineer to support development, optimization, transfer, scale-up, and commercialization of neurovascular medical-device products.

This hands-on role requires building repeatable, robust processes that meet regulatory requirements and quality systems. You will partner with R&D, Quality, Operations, suppliers, and leadership to continuously improve manufacturing capabilities.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field preferred.
• 3–5 years of relevant medical-device manufacturing engineering experience.
• Strong preference for neurovascular, cardiovascular, interventional, catheter, or implantable medical-device experience.
• Hands-on experience with small, complex medical-device assemblies.
• Experience with ISO 13485/FDA-regulated quality system.
• Experience with process development, process optimization, and manufacturing scale-up.
• Strong problem-solving and analytical skills.
• Ability to read and create engineering drawings and manufacturing documentation.
• Strong communication and cross-functional collaboration skills.
• Comfortable working in a startup environment with limited layers of management.

Responsibilities

• Develop, optimize, and scale manufacturing processes for neurovascular medical devices.
• Support transition of products from R&D/prototype development into production.
• Develop and improve assembly, forming, heat-setting, bonding, joining, cleaning, coating, inspection, packaging, and related manufacturing processes.
• Develop manufacturing work instructions, process specifications, tooling requirements, and process documentation.
• Identify manufacturing risks and implement appropriate controls.
• Support process validation, equipment qualification, and manufacturing verification activities.
• Develop fixtures, tooling, gauges, and manufacturing aids.
• Troubleshoot manufacturing problems and determine root causes.
• Support CAPA, NCR/nonconformance investigations, and continuous improvement activities.
• Work with suppliers and contract manufacturers on process development and production issues.
• Support manufacturing scale-up and production readiness.
• Establish appropriate in-process and final inspection requirements.
• Work closely with Quality to ensure manufacturing processes comply with applicable QMS requirements.
• Participate in design-transfer activities and design-for-manufacturability initiatives.
• Maintain accurate technical and manufacturing documentation.
• Help establish a scalable manufacturing infrastructure as Galaxy expands.

Skills

Problem solving

Cross-functional collaboration

Engineering drawings reading

Education

Bachelor's degree in Mechanical Engineering

Related field (Biomedical/Manufacturing) preferred

Job description

Galaxy Therapeutics is seeking a Neurovascular Manufacturing Engineer to support the development, optimization, transfer, scale-up, and commercialization of our neurovascular medical-device products.

About the Role

This is a hands-on engineering position for someone who understands that successful medical-device manufacturing requires more than designing a process—it requires developing a process that is repeatable, robust, documented, inspectable, scalable, and capable of meeting quality and regulatory requirements. The successful candidate will work closely with R&D, Quality, Operations, suppliers, and company leadership to establish and continuously improve manufacturing processes.

Responsibilities

• Develop, optimize, and scale manufacturing processes for neurovascular medical devices.
• Support transition of products from R&D/prototype development into production.
• Develop and improve assembly, forming, heat-setting, bonding, joining, cleaning, coating, inspection, packaging, and related manufacturing processes.
• Develop manufacturing work instructions, process specifications, tooling requirements, and process documentation.
• Identify manufacturing risks and implement appropriate controls.
• Support process validation, equipment qualification, and manufacturing verification activities.
• Develop fixtures, tooling, gauges, and manufacturing aids.
• Troubleshoot manufacturing problems and determine root causes.
• Support CAPA, NCR/nonconformance investigations, and continuous improvement activities.
• Work with suppliers and contract manufacturers on process development and production issues.
• Support manufacturing scale-up and production readiness.
• Establish appropriate in-process and final inspection requirements.
• Work closely with Quality to ensure manufacturing processes comply with applicable QMS requirements.
• Participate in design-transfer activities and design-for-manufacturability initiatives.
• Maintain accurate technical and manufacturing documentation.
• Help establish a scalable manufacturing infrastructure as Galaxy expands.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related field preferred.
• 3–5 years of relevant medical-device manufacturing engineering experience.
• Strong preference for neurovascular, cardiovascular, interventional, catheter, or implantable medical-device experience.
• Hands-on experience with small, complex medical-device assemblies.
• Experience working under an ISO 13485/FDA-regulated quality system.
• Experience with process development, process optimization, and manufacturing scale-up.
• Strong problem-solving and analytical skills.
• Ability to read and create engineering drawings and manufacturing documentation.
• Strong communication and cross-functional collaboration skills.
• Comfortable working in a startup environment with limited layers of management.

Required Skills

• Someone who can walk onto the manufacturing floor, understand a problem, identify the root cause, work with technicians and engineers to solve it, document the solution properly, and help turn that solution into a repeatable manufacturing process.

Preferred Skills

• Only candidates with relevant medical device experience who meet the qualifications above will be considered.

Pay range and compensation package

$115,000–$125,000 annually

Equal Opportunity Statement

Galaxy Therapeutics is committed to diversity and inclusivity.