AI
Senior Medical Device R&D Engineer
Accepting applicationsAngioSafe, Inc. · San Jose, CA
Full-Time Mid_senior aiateganrf
Posted
4d ago
Category
Test
Experience
Mid_senior
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.
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
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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.
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
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