Medical Device Engineer

AngioSafe • San Jose, CA

17d • 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

• 5 years of Medical Device R&D experience
• Working within ISO 13485 regulated Design Controls
• Adhering to document controls and completing document change orders
• Bachelor’s degree in mechanical engineering
• Hands on catheter prototyping and testing
• SolidWorks skills, including detail component and assembly 3D modeling and 2D specification drawings per ASME Y14.5
• Knowledge of materials selection and techniques for catheter manufacturing processes including braiding, lamination, laser welding, adhesive bonding, and packaging
• Effective communicator able to explain technical concepts to all members of the company
• Solid technical writing skills including the use of Word, Excel, PowerPoint
• Awareness and attention to high-level design goals and company direction
• Ability to organize and prioritize a variety of tasks in a small & rapidly changing organization
• High-level of maturity and self-motivation

Nice To Haves

• Support of regulatory submissions to FDA and Notified Bodies
• Use of cloud-based Document Control Systems
• Project leadership/management experience

Responsibilities

• Lead sub projects and contribute to the design, development, testing, and manufacturing transfer of interventional catheters including sustaining engineering activity for existing products
• Generate technical documentation of designs, evaluations, and testing in accordance with design control standards
• Generate test methods, protocols, and reports for concept evaluation, verification & validation, sustaining engineering product design iterations, component qualifications, and packaging/shelf-life validations
• Hands on building and/or testing of new and existing devices in the AngioSafe portfolio
• Oversee R&D technician’s work including testing and prototype assembly
• Generate new or update existing manufacturing process instructions, bill of materials, product engineering specifications, and risk management documentation
• Work with suppliers to develop and meet internal component specifications including incoming inspection non-conformance resolution
• Help maintain a shared test and prototype lab space

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees