Senior Device Engineer - Lifecycle Management

About the Role

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. This role focuses on continuous improvement of existing products and requires strong technical skills complemented by great communication and teamwork qualities.

Responsibilities

• Lead and manage small-scale projects for on-time deliverables.
• 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.
• Perform 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.

Requirements

• BS in Software Engineering or equivalent degree and/or experience. Advanced degree desirable.
• Minimum of 8+ years of experience in engineering design and at least 5 years of experience with embedded Windows programming using C# and .NET.
• At least 3 years of experience in medical devices or a similarly controlled software environment preferred.
• Experience in developing event-driven, multi-threaded Windows-based applications using .NET Framework and C# preferred.
• Required experience in structured software and systems development and integration, including software design methodologies, design patterns, and component-oriented software architecture to produce high-quality software applications.
• Experience with common protocols such as RS232, SPI, and USB is a plus.
• Knowledge of PID control algorithms.
• 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.
• Proficiency in MS Office, including Word and Excel.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) to eligible employees.
• Eligibility to participate in long-term incentive programs.