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AbbVie

Senior Device Engineer - Lifecycle Management

Posted 7 Days Ago
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Hybrid
Pleasanton, CA, USA
Senior level
Hybrid
Pleasanton, CA, USA
Senior level
Lead lifecycle management for medical device software: define requirements, design and implement embedded/Windows applications, integrate and debug hardware/software, execute V&V tests, produce regulated documentation, drive quality and process improvements in compliance with FDA QSR, ISO13485 and IEC 62304.
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Company Description

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow us on LinkedIn, Facebook, Instagram, X and YouTube.

 

Job Description

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.

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.

Qualifications

  • BS in Software Engineering or equivalent degree and/or experience. Advanced degree desirable.
  • 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. 
  • 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 experience in software design methodologies, design patterns, component-oriented software architecture to produce high-quality software applications.
  • 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. 
  • Proficiency in MS Office, including Word and Excel.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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