Senior Device Engineer - Lifecycle Management

Allergan Aesthetics•Irvine, CA

16h

About The Position

The Senior Software Engineer - Lifecycle Management will work collaboratively with a team to support medical device products from the transfer to production through product end of life. The Engineer will have a technical leadership role for supporting components and subassemblies of the body contouring products and will closely interact with a multi-disciplined Engineering team consisting of electrical, software and mechanical groups. The individual works within cross-functional teams and provides software requirements, design and implementation for current generation software and systems projects. He or she develops a thorough understanding of design requirements to ensure that the system’s objectives are properly defined and ultimately achieved. This role is focused on continuous improvement of existing products. This individual must have strong technical skills complemented by great communications and teamwork qualities. Experience in a software development background in a structured/regulated environment such as medical device development is required.

Requirements

BS in Software Engineering or equivalent degree and/or experience.
Minimum of 8+ years experience in engineering design and at least 5 years of experience with embedded Windows programming with C# and . NET.
At least 3 years of experience in medical devices or similarly controlled software environment preferred.
Required experience in structured software and systems development and integration, including experience in software design methodologies, design patterns, component-oriented software architecture to produce high-quality software applications.
Proficiency in MS Office, including Word and Excel.

Nice To Haves

Advanced degree desirable.
Experience in developing event driven, multi-threaded Windows-based applications using .NET Framework and C# preferred.
Experience with common protocols: RS232, SPI, USB a plus.
Knowledge of PID control algorithm.
Knowledge of software life cycle processes used in regulated development environments such as IEC 62304.
Result-oriented, self-motivated and able to participate as both a team member and an individual contributor.

Responsibilities

Lead and manage small scale projects for on time deliverable.
Contribute to requirements definition at the functional level and work with cross functional groups.
Perform in-depth data analysis and drive improvements to software or product quality.
Design, develop, and support embedded, Windows embedded and desktop applications.
Participate in software work product reviews/inspections.
Interface, integrate, troubleshoot and debug software and hardware components.
Generate required product development documentation including functional specifications and design documents.
Execute manual or automated tests for verification and validation of software applications.
Design, code and validate software tools for use in the verification and manufacturing of the product.
Work with Software Verification, Product Support and Manufacturing to resolve software issues.
Drive improvements to process quality.
Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which AbbVie complies.