R&D Engineer

  • Job Reference: 68380542-2
  • Date Posted: 27 July 2018
  • Recruiter: Deerfield Management
  • Location: Irvine, California
  • Salary: On Application
  • Sector: Engineering
  • Job Type: Permanent

Job Description

Overview

Exciting new medical device incubator in Irvine, CA area, which provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Responsibilities

KEY RESPONSIBILITIES

The position requires collaboration with physicians, coworkers in R&D, and contractors. Requires a working knowledge of Regulatory, Quality Systems, and Manufacturing to assist in development of new products. Interaction with domestic component suppliers and contract manufacturers is expected. The R&D Engineer position is responsible for developing, testing and improving new medical device concepts and devices. Requires the ability to dive into medical literature and procedures to develop a deep understanding of the state of medical practice, competition, standard-of-care, outcomes, and basic medico-economics.

ESSENTIAL FUNCTIONS

Responsible for working with other members of engineering team and vendors to design, prototype, develop, test and troubleshoot medical device and mechanical assemblies in accordance with established policies, goals and objectives.

  • A minimum of two years of creative design expertise using ProE or Solidworks.
  • Must be able to demonstrate strong skills as an innovator and problem solver. Hands-on experience with catheter design and implants.
  • Requires the proven ability to apply technical knowledge and judgment to complex technical problems and technical proficiency specific to mechanical problem solving in medical device design.
  • Prepare appropriate design documentation in accordance with quality system requirements.
  • Plans the fabrication of prototype components and systems, in conjunction with the development of methods and procedures for testing products or systems.
  • Support inhouse and outsourced production to ensure that quality
  • Other activities as required to support company objectives.


PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • 3+ years medical device engineering experience in R&D
  • Medical device implant and catheter systems/delivery systems development
  • Imaging and guidance expertise required
  • Knowledge and experience with ISO & FDA Quality System requirements
  • Language Ability: Ability to communicate and interpret conceptual ideas, project requirements, part & system specifications, engineering analyses & test data with cross-functional team, vendors and external resources. Both verbal and written English speaking and writing skills required
  • Math Ability: Ability to employ standard engineering analysis to problems of statics & mechanics
  • Reasoning Ability: Strong analytical and problem-solving skills, Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Computer Skills: SolidWorks Computer Aided Design (CAD), Microsoft office.
  • Basic knowledge of lab/shop practices, safety, procedures, and tools/equipment involved in but not limited to prototype development, product verification, and test method validation.

Job Type: Full-time