Medical Device R&D Engineer

• →Contribute to the design, development, testing, and manufacturing transfer of interventional catheter devices
• →Support development activities for both new and existing products
• →Perform hands-on prototyping, assembly, 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
  • →component qualification
  • →packaging and shelf-life validation
• →Support creation and maintenance of:
  • →Bills of Materials (BOMs)
  • →manufacturing process instructions
  • →engineering specifications
  • →risk management documentation
• →Work closely with suppliers to support component development and resolve non-conformance issues
• →Assist in maintaining shared laboratory and prototype spaces
• →Collaborate cross-functionally with engineering, manufacturing, quality, and leadership teams
  

• Bachelor’s degree in Mechanical Engineering or related engineering discipline preferred
• Minimum 5 years of medical device R&D experience
• Hands-on catheter prototyping and testing experience required
• Experience working within ISO 13485 Design Controls required
• Experience with document control systems and engineering change documentation
• Strong hands-on engineering and troubleshooting abilities
• Startup and/or small-company experience preferred
• Proficiency with SolidWorks 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 communication and technical writing skills
• Ability to manage multiple priorities in a fast-paced environment
• Self-motivated with strong ownership mentality
  

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

• 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