Sr Medical Device Engineer

AngioSafe•San Jose, CA

1d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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