Sr. Software Dev. Quality Engineer- NPS Validation

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.Our Neuromodulation business is an area of expertise for Abbott. This business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. Our Solutions include Proclaim (TM) XR SCS System, the 1 Spinal cord stimulator on the market, Proclaim (TM) DRG Neurostimulator, the only FDA approved DRG therapy and a market leader in radiofrequency ablation therapy, Abbott RFA. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Our deep brain stimulation technology for progressive diseases help people manage their Parkinson''s disease and essential tremor symptoms, steering away from side effects.Our location in Plano, TX currently has an opportunity for an experienced, high caliber Software Development Quality Engineer to assure new or modified products conform to quality standards and establish 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 Neuromodulation 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.WHAT YOU''LL DO Execute and support on-time completion of Design Control DeliverablesRepresent Quality Assurance on cross-functional development teams to provide guidance and support for design controls, risk management, and regulatory strategySupport Design Verification and Validation planning & execution, including active cross- functional root-cause analysis investigation & resolution activitiesSupport and lead validation activities for product and non-product systems.Support Risk Management activities from product Concept through CommercializationDesign and perform acceptance testing on software systemsSupport DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gapsSupport manufacturing process development & qualification for new product commercialization and product changesSupport the establishment of objective, measurable, discrete, and verifiable customer and product requirementsSupport the ongoing maintenance of the quality system (internal and external audits, CAPA, NCMR, complaints) and lead proactive quality system improvementsContribute to product design reviews, risk analyses, and document reviewsAutomate processes and software/systems testingPerform Software Configuration Management tasks.EDUCATION AND EXPERIENCE YOU''LL BRINGRequiredBachelor''s degree in Computer Science, Computer Engineering or Electrical EngineeringMinimum 8 years'' experience in medical device development and/or other highly regulated industryWorking knowledge of 21 CFR part 820, IEC 62304, IEC 82304-1, ISO 14971, and ISO 13485Experience with software development, using languages such as C, C++, C, or JavaExperience with systems engineering, system requirements management, and system level risk management strategiesAbility to work within a team and as an individual contributor in a fast-paced, changing environmentAbility to work in a highly matrixed and geographically diverse business environmentMeticulous and methodical with high attention to detail. Solid communication and interpersonal skills.Preferred Advanced degree (e.g. MS) or equivalent practical experienceExperience with Class III medical devicesStrong 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 organizationMultitasks, prioritizes and meets deadlines in timely mannerStrong organizational and follow-up skillsWHAT WE OFFERAt Abbott, you can have a good job that can grow into a great career. We offer:• Training and career development, with onboarding programs for new employees and tuition assistance• Financial security through competitive compensation, incentives and retirement plans• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs• Paid time off• 401(k) retirement savings with a generous company match• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Created: 2021-11-29