AngioSafe, Inc. · 3 weeks ago
Senior Medical Device R&D Engineer
San Jose, CA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expAngioSafe, Inc. is a Bay Area start-up focused on improving healthcare through innovative vascular interventional catheter device design and development. They are seeking a highly motivated Senior Medical Device R&D Engineer to lead the design, development, prototyping, testing, and manufacturing transfer of interventional catheter devices, impacting their device portfolio significantly.
Medical DeviceHealthcareHealth DiagnosticsMedical
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
Qualification
Required
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
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
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
Company
AngioSafe, Inc.
AngioSafe® is redefining revascularization through the development of technologies that safely, efficiently, and predictably empower interventionalists to tackle complex lesions.
51-200 employees
H1B Sponsorship
AngioSafe, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
100%
Represents job field similar to this job
Engineering and Development
Trends of Total Sponsorships
*2024 (1)
2021 (1)
Funding
Current Stage
Growth StageCompany data provided by crunchbase