Company: Galaxy Therapeutics Inc.

Location: Milpitas, CA

Job Type: Full-time

About Galaxy Therapeutics Inc.:

Galaxy Therapeutics is a private, US-based, clinical-stage medical device company specializing in treating brain aneurysms with our proprietary implant technology. We are addressing a significant $1B market opportunity with our Saccular Endovascular Aneurysm Lattice treatment system: Seal™. Having successfully demonstrated proof of concept, clinical safety, and efficacy with our Pre SEAL IT trial, we are now working with the FDA to launch our Pre-Market Approval SEAL-IT trial in the US and internationally. Our core team, based in Milpitas, CA, consists of experts in neuro-intervention and medical device development.

About the Role:

We are seeking a seasoned Senior Research and Development Engineer to lead our product development initiatives. This role involves overseeing the design, testing, fabrication, and validation of our medical devices and supporting systems. As a leader within the R&D team, you will mentor fellow engineers and technicians, ensuring alignment with the company’s goals. You will collaborate across departments, engage with suppliers, and contribute to our ongoing success.

Key Responsibilities:

- Utilize advanced engineering principles to research, design, develop, and evaluate materials, components, assemblies, processes, and equipment.

- Communicate designs and technical requirements effectively through verbal and written communication.

- Lead projects from concept through market release, functioning as the Project Leader.

- Contribute to marketing and engineering specifications, feasibility studies, cost analyses, design reviews, risk assessments, and product verification and validation.

- Participate in FMEA analyses and ensure compliance with quality system procedures.

- Document detailed drawings and specifications throughout all stages of research and development.

- Direct and coordinate support personnel activities in project execution.

- Develop new processes, modify existing ones, and enhance tooling and fixtures to improve performance, efficiency, and production yields.

- Coordinate with suppliers to support development efforts.

- Implement process improvements to reduce lead time, eliminate non-value-added work, and enhance process capabilities.

- Build prototypes manually according to engineering instructions, drawings, and specifications.

- Write and submit intellectual property disclosures and participate in patent reviews.

- Attend animal studies as required.

- Perform additional duties as assigned to support the company's overall objectives.

Qualifications and Skills:

- Microcatheter and access catheter expertise preferred.

- Bachelor’s degree in Biomedical, Mechanical, or Biomedical Science, or a related field.

- 5-10 years, ore more, of experience in medical design within a medical device or clinical environment.

- Proficiency in SolidWorks/CAD, word processing, spreadsheet, and project management software.

- Ability to use required safety equipment during lab work and animal/cadaver lab work.

- Ability to attend human clinical cases and interact professionally with hospital staff.

- Strong ability to manage multiple deadlines, work under pressure, and maintain cooperative working relationships.

- Knowledge of vascular interventional medical products and technologies, particularly catheters and/or stents.

- Familiarity with regulatory requirements of the medical device industry, including GMPs and GLPs.

- Strong analytical and communication skills.

Why Join Us?

Galaxy Therapeutics offers the opportunity to be at the forefront of groundbreaking medical technology that addresses a critical health issue. You will work alongside a team of dedicated professionals and play a key role in our mission to innovate and improve patient outcomes.

Application Process:

Interested candidates are encouraged to submit their resume and a cover letter detailing their qualifications and experience.

***Galaxy Therapeutics Inc. is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Galaxy Therapeutics

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