Abbott Software Development Quality Engineer II in Sylmar, California

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.

JOB DESCRIPTION:

We are seeking an experienced, high caliber Software Development Quality Engineer II assure new or modified products conform to quality standards and establishes compliance with the quality system. You will be responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This is a hands-on role where you will apply self-directed and diversified engineering and quality principles to our devices and systems. The quality engineer will support legacy CRM and Neuro software product development. They will help maintain the quality system, ensure that all processes are efficient and followed during the development lifecycle, champion process improvement, gain domain knowledge over the product, help troubleshoot issues, protect the business during audits, and seek to improve the quality of products.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Impact this role will have on Abbott:

  • Execute and support on-time completion of Design Control Deliverables

  • Represent Quality Assurance on cross-functional development teams to provide guidance and support for design controls, risk management, and regulatory strategy

  • Support Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities

  • Support Risk Management activities from product Concept through Commercialization

  • Design and perform acceptance testing on software systems

  • Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

  • Support manufacturing process development & qualification for new product commercialization and product changes

  • Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements

  • Support the ongoing maintenance of the quality system (internal and external audits, CAPA, NCMR, complaints) and lead proactive quality system improvements

  • Contribute to product design reviews, risk analyses, and document reviews

  • Automate processes and software/systems testing

Your experience(s), education and knowledge will further expand Abbott’s marketplace success:

  • Bachelor level degree in Computer Science or equivalent practical experience

  • 3-5 years’ experience in medical device development and/or other highly regulated industry

  • Working knowledge of 21 CFR part 820, IEC 62304, IEC 82304-1, ISO 14971, and ISO 13485

  • Experience with software development, using languages such as C, C++, C#, or Java

  • Experience with systems engineering, system requirements management, and system level risk management strategies

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment

  • Ability to work in a highly matrixed and geographically diverse business environment

  • Meticulous and methodical with high attention to detail

  • Solid communication and interpersonal skills

  • Ability to travel approximately 10%

  • Ability to maintain regular and predictable attendance

Your preferred qualifications and education:

  • Advanced degree (e.g. MS) or equivalent practical experience

  • Experience with Class III medical devices

  • Strong foundation in computer science, with strong competencies in data structures, algorithms, and software design

  • Capable of deep-dives into code

  • Strong verbal and written communications with ability to effectively strategize and communicate at multiple levels in the organization

  • Multitasks, prioritizes and meets deadlines in timely manner

  • Strong organizational and follow-up skills

JOB FAMILY:

Operations Quality

DIVISION:

ASJM Abbott St. Jude Medical

LOCATION:

United States of America > Sylmar > S4497 : 15900 Valley View Court

ADDITIONAL LOCATIONS:

United States of America > Sunnyvale > S4494 : 645 Almanor Ave

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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