Galaxy Therapeutics
Principal R&D Engineer, Microcatheter Development
Galaxy Therapeutics, Milpitas, California, United States, 95035
Principal R&D Engineer, Microcatheter Development
Potential Role Expansion to VP R&D for the right hands-on candidate
Location:
Milpitas, CA Department:
Engineering Reports to:
Chief Operating Officer Salary Range:
$100,000 – $200,000 Experience:
10+ years in medical device development About Galaxy Therapeutics Inc. Galaxy Therapeutics is a private, US-based, clinical stage medical device company pioneering implant technology to treat brain aneurysms. Our Saccular Endovascular Aneurysm Lattice treatment system, Seal, addresses a $1B+ market opportunity. We have demonstrated proof of concept and clinical safety in our Pre-SEAL IT trial and are currently enrolling in our Pre-Market Approval SEAL-IT trial in the US and internationally. Our core team is based in Milpitas, CA. About the Role As Principal R&D Engineer, you will lead product development for our microcatheter product line, from concept through market release. This hands-on role is ideal for a technical leader who thrives in a collaborative, fast-paced environment and is passionate about innovation in medical devices. Key Responsibilities Lead projects from concept to market release, acting as Project Leader. Design, develop, test, and validate microcatheter systems and supporting devices. Mentor and guide engineers and technicians; foster cross-functional collaboration. Develop and execute engineering specifications, feasibility plans, cost analysis, risk assessments, FMEAs, and product verification/validation testing. Ensure compliance with quality system procedures and regulatory requirements. Document detailed drawings and specifications throughout R&D stages. Build prototypes and participate in animal studies as required. Drive process improvements to enhance performance, efficiency, and production yields. Write and submit intellectual property disclosures; participate in patent reviews. Perform additional duties as needed to support company objectives. Qualifications Bachelor’s degree in Biomedical, Mechanical, or Biomedical Science, or related field (advanced degree preferred). 10+ years of experience in medical device design and development, including 7+ years with intravascular products (catheters, guidewires, balloons, stents). Proven experience as a technical lead, taking products from concept to launch (microcatheter experience preferred). Proficiency in SolidWorks/CAD, word processing, spreadsheets, and project management software. Strong skills in product design/testing, statistical data analysis, technical writing, and communication. Ability to work under pressure, meet deadlines, and collaborate effectively. Knowledge of vascular interventional medical products and regulatory requirements (GMPs, GLPs). Ability to attend clinical cases and interact professionally with hospital staff. Supervisory Responsibilities R&D Technician (all levels) Why Join Us? Opportunity to make a significant impact in a growing, innovative company. Work alongside leading physicians and engineers in the field. Potential for role expansion to VP R&D for the right candidate. Equal Opportunity Employer Galaxy Therapeutics Inc. is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Ready to make a difference? Apply now and join us in revolutionizing brain aneurysm treatment!
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Milpitas, CA Department:
Engineering Reports to:
Chief Operating Officer Salary Range:
$100,000 – $200,000 Experience:
10+ years in medical device development About Galaxy Therapeutics Inc. Galaxy Therapeutics is a private, US-based, clinical stage medical device company pioneering implant technology to treat brain aneurysms. Our Saccular Endovascular Aneurysm Lattice treatment system, Seal, addresses a $1B+ market opportunity. We have demonstrated proof of concept and clinical safety in our Pre-SEAL IT trial and are currently enrolling in our Pre-Market Approval SEAL-IT trial in the US and internationally. Our core team is based in Milpitas, CA. About the Role As Principal R&D Engineer, you will lead product development for our microcatheter product line, from concept through market release. This hands-on role is ideal for a technical leader who thrives in a collaborative, fast-paced environment and is passionate about innovation in medical devices. Key Responsibilities Lead projects from concept to market release, acting as Project Leader. Design, develop, test, and validate microcatheter systems and supporting devices. Mentor and guide engineers and technicians; foster cross-functional collaboration. Develop and execute engineering specifications, feasibility plans, cost analysis, risk assessments, FMEAs, and product verification/validation testing. Ensure compliance with quality system procedures and regulatory requirements. Document detailed drawings and specifications throughout R&D stages. Build prototypes and participate in animal studies as required. Drive process improvements to enhance performance, efficiency, and production yields. Write and submit intellectual property disclosures; participate in patent reviews. Perform additional duties as needed to support company objectives. Qualifications Bachelor’s degree in Biomedical, Mechanical, or Biomedical Science, or related field (advanced degree preferred). 10+ years of experience in medical device design and development, including 7+ years with intravascular products (catheters, guidewires, balloons, stents). Proven experience as a technical lead, taking products from concept to launch (microcatheter experience preferred). Proficiency in SolidWorks/CAD, word processing, spreadsheets, and project management software. Strong skills in product design/testing, statistical data analysis, technical writing, and communication. Ability to work under pressure, meet deadlines, and collaborate effectively. Knowledge of vascular interventional medical products and regulatory requirements (GMPs, GLPs). Ability to attend clinical cases and interact professionally with hospital staff. Supervisory Responsibilities R&D Technician (all levels) Why Join Us? Opportunity to make a significant impact in a growing, innovative company. Work alongside leading physicians and engineers in the field. Potential for role expansion to VP R&D for the right candidate. Equal Opportunity Employer Galaxy Therapeutics Inc. is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Ready to make a difference? Apply now and join us in revolutionizing brain aneurysm treatment!
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