Medical Device Validation Engineer Jobs in San Ramon, CA

AngioSafe is a Bay Area start-up focused on improving healthcare through state-of-the-art vascular interventional catheter device design, development, and manufacturing. We are pioneering the development of novel treatment mechanisms and algorithms to provide unprecedented access to peripheral and coronary disease treatments. Our experienced team is committed to developing and commercializing innovative, high-quality products that reduce risk and improve cardiovascular treatment outcomes. This onsite role will have a meaningful and direct impact on AngioSafe's device portfolio through the development of novel vascular interventional devices and support of existing product pipelines.

Position Summary

We are seeking a highly motivated, hands-on Senior Medical Device R&D Engineer to support the design, development, prototyping, testing, and manufacturing transfer of interventional catheter devices. This is a highly visible Individual Contributor (IC) role requiring both technical leadership and strong execution skills. The ideal candidate is a do-er who enjoys hands-on engineering work, thrives in a startup environment, and can independently drive projects while collaborating across multidisciplinary teams.
Roles and Responsibilities

• Lead technical projects related to the design, development, testing, and manufacturing transfer of interventional catheter devices
• Provide technical leadership while remaining highly hands-on in day-to-day engineering activities
• Support development activities for both new and existing products, including sustaining engineering efforts
• Perform hands-on prototyping, troubleshooting, and testing of medical devices
• Generate technical documentation in accordance with Design Control requirements
• Develop test methods, protocols, and reports for:
  • concept evaluations
  • verification & validation testing
  • sustaining engineering product iterations
  • component qualification
  • packaging and shelf-life validation
• Oversee and support R&D technician activities including testing and prototype assembly
• Generate and maintain:
  • Bills of Materials (BOMs)
  • manufacturing process instructions
  • engineering specifications
  • risk management documentation
• Work directly with suppliers to support component development and resolve non-conformance issues
• Collaborate cross-functionally with manufacturing, quality, regulatory, and leadership teams
• Help maintain shared lab and prototype spaces
  

Minimum Qualifications

• Bachelor's degree in Mechanical Engineering
• Minimum 10 years of medical device R&D experience
• Strong working knowledge of ISO 13485 regulated Design Controls
• Experience adhering to document control systems and completing engineering change documentation
• Hands-on catheter prototyping and testing experience required
• Strong hands-on engineering mindset with ability to independently prototype, build, troubleshoot, and iterate device concepts
• Startup and/or small-company experience preferred
• Proven ability to operate effectively as a technical Individual Contributor in a fast-paced environment
• SolidWorks proficiency including:
  • 3D component and assembly modeling
  • 2D drawings per ASME Y14.5
• Knowledge of catheter manufacturing materials and processes including:
  • braiding
  • lamination
  • laser welding
  • adhesive bonding
  • packaging
• Strong technical writing and documentation skills required
• Excellent verbal and written communication skills
• Ability to explain technical concepts across multidisciplinary teams
• Ability to manage multiple priorities in a rapidly changing organization
• High level of maturity, accountability, and self-motivation
  

Preferred Qualifications

• Catheter design and development experience strongly preferred
• Experience supporting FDA and/or Notified Body regulatory submissions
• Experience using cloud-based document control systems
• Demonstrated technical project leadership experience preferred
  

Additional Information

• This is a fully onsite role based in San Jose, CA
• No relocation or immigration sponsorship available
• Principals only please
  

Equal Opportunity Employer
AngioSafe is committed to a diverse workplace and is committed to equal opportunity employment for all job applicants without regard to race, color, religion, sex, sexual orientation, age, gender, gender identity or expression, size, national origin, disability, or veteran status. AngioSafe complies with all applicable local, state, and national laws governing non-discrimination in employment