Senior Medical Device R&D Engineer

US·San Josesenior

EngineeringR&D Engineer

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Quick Summary

Overview

AngioSafe is a Bay Area start-up focused on improving healthcare through state-of-the-art vascular interventional catheter device design, development, and manufacturing.

Requirements Summary

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…

Technical Tools

documentationtechnical-writing

Responsibilities

~1 min read

→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

Requirements

~1 min read

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

Requirements

~1 min read

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

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