Sr Medical Device Engineer

AngioSafe is a Bay Area start-up focusing 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 seasoned experts are committed to developing and commercializing high quality and innovative products to decrease risk and improve outcomes of cardiovascular 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:

• Technical Project Leadership

• Lead and contribute to the design, development, manufacturing transfer, and sustaining engineering support of interventional catheters

• Conceptualize and iterate device and component designs from brainstorm through concept realization and design verification & validation to manufacturing transfer

• Generate or update manufacturing process instructions, bills of material, development plans, product specifications, and risk management documentation

• Generate test methods, protocols, and reports for concept evaluation, design verification & validation, component qualifications, and packaging/shelf-life validations

• Generate high quality technical documentation of designs, evaluations, and testing in accordance with document and design controls

• Be part of a cross-functional team to define and accomplish research and development goals

• Perform and oversee testing of new and existing devices in the AngioSafe portfolio

• Oversee R&D technician’s work including testing and prototype assembly

• 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:
• 10 years of medical device R&D experience
o Working within ISO 13485 regulated Design Controls environment
o Adhering to document controls and completing document change orders
• 5 years of project leadership/management experience
o Attention to high-level design goals and company direction
• Bachelor’s degree in mechanical engineering
• Vascular catheter device design, development, and manufacturing transfer including generation of all documentation required for component specifications, assembly drawings and manufacturing instructions
• SolidWorks skills, including detail component and assembly 3D modeling and 2D specification drawings per ASME Y14.5
• Design for Manufacturing based on extensive knowledge of materials selection and catheter manufacturing processes including braiding, lamination, laser welding, adhesive bonding, and packaging
• Hands on catheter prototyping and testing
• Excellent technical writing and communication skills
o Design Verification & Validation test method, protocol and report writing for vascular catheters
o Design History File document generation across all Phases of the product life cycle
• Effective communicator able to explain technical concepts to all members of the company
• Ability to organize and prioritize a variety of tasks in a small & rapidly changing organization
• Capable of working independently and with a cross functional team
• High-level of maturity and self-motivation

Preferred Skills and Experience:
• Regulatory submissions to FDA and Notified Bodies
• Support of technical audits
• Use of cloud-based Document Control Systems, specifically Master Control

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

Salary : $150,000 - $225,000