AI
Medical Device R&D Engineer
Accepting applicationsAngioSafe, Inc. · San Jose, CA
Full-Time Entry aiaterf
Posted
5d ago
Category
Test
Experience
Entry
Country
United States
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.
The ideal candidate will combine strong engineering fundamentals with hands-on technical ability and thrive in a fast-paced startup environment.
Position Summary
We are seeking a highly motivated, hands-on Individual Contributor (IC) R&D Engineer to support the design, development, prototyping, testing, and manufacturing transfer of interventional catheter devices.
This role is ideal for someone who enjoys building and testing devices directly, solving technical challenges, and working collaboratively within a small, rapidly evolving medical device company.
Roles and Responsibilities
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
Minimum Qualifications
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
Preferred Qualifications
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
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
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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.
The ideal candidate will combine strong engineering fundamentals with hands-on technical ability and thrive in a fast-paced startup environment.
Position Summary
We are seeking a highly motivated, hands-on Individual Contributor (IC) R&D Engineer to support the design, development, prototyping, testing, and manufacturing transfer of interventional catheter devices.
This role is ideal for someone who enjoys building and testing devices directly, solving technical challenges, and working collaboratively within a small, rapidly evolving medical device company.
Roles and Responsibilities
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
Minimum Qualifications
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
Preferred Qualifications
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
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
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