AngioSafe
Overview:
AngioSafe is a Bay Area start-up focusing on improving healthcare delivery 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 seasoned experts are committed to designing, testing, manufacturing, conducting clinical trials, seeking regulatory approvals, and commercializing high quality and innovative products to decrease risk and improve outcomes of arterial disease treatment.
This onsite role will have a meaningful and direct impact on AngioSafe's device portfolio through development of novel vascular interventional devices and support of our existing device pipeline. The ideal candidate will bring both theoretical and hands-on ability to design and implement new concepts and processes in support of high quality, high capacity and sustainable product lines.
Roles and Responsibilities:
Lead sub projects and contribute to the design, development, testing, and manufacturing transfer of interventional catheters including sustaining engineering activity for existing products.
Conceptualize and iterate device and component designs and drawings from brainstorm to concept realization to design verification & validation (V&V) followed by manufacturing transfer
Generate test methods, protocols, and reports for concept evaluation, verification & validation, cost reduction sustaining engineering product design iterations, component supplier qualifications, and packaging/shelf life validations.
Be part of a cross-functional team to define and accomplish research and development goals
Oversee R&D technician's work including testing and prototype assembly
Perform and oversee testing of new and existing devices in the AngioSafe portfolio.
Generate high quality technical documentation of designs, evaluations, and testing in accordance with design controls standard operating procedures
Generate or update new and existing product design manufacturing instructions, bills of material, development plans, product specifications, and risk management documentation (DFMEA and Use Hazard Analysis).
Work with component suppliers to develop and meet internal design specifications including non conformance incoming quality inspection issue resolution.
Help maintain a shared test and prototype lab space
Minimum Skills and Experience:
5 Years or greater of Medical Device R&D Experience
Bachelor's degree in Mechanical Engineering
Vascular catheter device design, development, and manufacturing transfer including generation of all documentation required from component specifications to assembly drawings and manufacturing instructions with an attention to Design for Manufacturing (DFM).
SolidWorks CAD skills, including detail component, sub assembly, final assembly, and packaging 3D modeling and 2D specification drawings per ASME Y14.5 norms
Extensive knowledge of materials selection and device design for catheter manufacturing processes including braiding, lamination, laser welding, adhesive bonding, and packaging.
Excellent technical writing skills including the use of Word, Excel, PowerPoint, Teams, etc.
Design Verification & Validation test method, protocol and report writing for vascular catheters
Working within ISO 13485 regulated Design Controls environment including Design History File document generation across all Phases of the product life cycle.
Hands on device prototyping and testing
Effective communicator able to explain technical concepts to all members of the company
Awareness and attention to high-level design goals and company direction
Ability to multi-task, organize and prioritize work
Innate flexibility to take on a variety of tasks in a small & rapidly changing organization
Document controls with keen attention to detail
Ability to work independently and with a cross functional team
High-level of maturity and self-motivation including creative problem-solving skills
**
**
Compensation:
AngioSafe offers competitive compensation and benefits. Pay for the successful candidate will depend on various factors (e.g. qualifications, education, prior experience).
Benefits
:
Medical, Dental, Vision, & Life
Paid Time Off + Holidays
Hybrid work environment (role dependent)
401K
Company Equity
Principals only Please
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.
AngioSafe is a Bay Area start-up focusing on improving healthcare delivery 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 seasoned experts are committed to designing, testing, manufacturing, conducting clinical trials, seeking regulatory approvals, and commercializing high quality and innovative products to decrease risk and improve outcomes of arterial disease treatment.
This onsite role will have a meaningful and direct impact on AngioSafe's device portfolio through development of novel vascular interventional devices and support of our existing device pipeline. The ideal candidate will bring both theoretical and hands-on ability to design and implement new concepts and processes in support of high quality, high capacity and sustainable product lines.
Roles and Responsibilities:
Lead sub projects and contribute to the design, development, testing, and manufacturing transfer of interventional catheters including sustaining engineering activity for existing products.
Conceptualize and iterate device and component designs and drawings from brainstorm to concept realization to design verification & validation (V&V) followed by manufacturing transfer
Generate test methods, protocols, and reports for concept evaluation, verification & validation, cost reduction sustaining engineering product design iterations, component supplier qualifications, and packaging/shelf life validations.
Be part of a cross-functional team to define and accomplish research and development goals
Oversee R&D technician's work including testing and prototype assembly
Perform and oversee testing of new and existing devices in the AngioSafe portfolio.
Generate high quality technical documentation of designs, evaluations, and testing in accordance with design controls standard operating procedures
Generate or update new and existing product design manufacturing instructions, bills of material, development plans, product specifications, and risk management documentation (DFMEA and Use Hazard Analysis).
Work with component suppliers to develop and meet internal design specifications including non conformance incoming quality inspection issue resolution.
Help maintain a shared test and prototype lab space
Minimum Skills and Experience:
5 Years or greater of Medical Device R&D Experience
Bachelor's degree in Mechanical Engineering
Vascular catheter device design, development, and manufacturing transfer including generation of all documentation required from component specifications to assembly drawings and manufacturing instructions with an attention to Design for Manufacturing (DFM).
SolidWorks CAD skills, including detail component, sub assembly, final assembly, and packaging 3D modeling and 2D specification drawings per ASME Y14.5 norms
Extensive knowledge of materials selection and device design for catheter manufacturing processes including braiding, lamination, laser welding, adhesive bonding, and packaging.
Excellent technical writing skills including the use of Word, Excel, PowerPoint, Teams, etc.
Design Verification & Validation test method, protocol and report writing for vascular catheters
Working within ISO 13485 regulated Design Controls environment including Design History File document generation across all Phases of the product life cycle.
Hands on device prototyping and testing
Effective communicator able to explain technical concepts to all members of the company
Awareness and attention to high-level design goals and company direction
Ability to multi-task, organize and prioritize work
Innate flexibility to take on a variety of tasks in a small & rapidly changing organization
Document controls with keen attention to detail
Ability to work independently and with a cross functional team
High-level of maturity and self-motivation including creative problem-solving skills
**
**
Compensation:
AngioSafe offers competitive compensation and benefits. Pay for the successful candidate will depend on various factors (e.g. qualifications, education, prior experience).
Benefits
:
Medical, Dental, Vision, & Life
Paid Time Off + Holidays
Hybrid work environment (role dependent)
401K
Company Equity
Principals only Please
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.