Medical Device RD Engineer

AngioSafe; San Jose (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

A medical device startup in San Jose is seeking an experienced professional to lead the design and development of interventional catheters. This role involves generating technical documentation, overseeing R&D activities, and prototyping. Candidates should have 5+ years of R&D experience in the medical device industry, a Bachelor’s degree in mechanical engineering, and proficiency in SolidWorks. The position is onsite and offers a dynamic work environment focused on innovative healthcare solutions.

Qualifications

• 5 years of Medical Device R&D experience required.
• Hands-on catheter prototyping and testing experience.
• Ability to organize and prioritize tasks in a rapid environment.

Responsibilities

• Lead design and development of interventional catheters.
• Generate technical documentation in accordance with design controls.
• Oversee testing and prototyping activities.

Skills

Medical Device R&D experience

SolidWorks skills

Hands-on catheter prototyping

Effective communication

Technical writing skills

Education

Bachelor’s degree in mechanical engineering

Tools

Document Control Systems

Job description

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

• 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

Minimum Skills and Experience

• 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

Preferred Skills and Experience

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

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.