Software Design Quality Engineer

Software Design Quality EngineerAbbott 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 115,000 colleagues serve people in more than 160 countries.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:Career development with an international company where you can grow the career of which you dream.Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.An excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.The OpportunityWe currently have an opening for a Software Design Quality Engineer for the Vascular division. This role is located at our Westford, MA location. This is a fully onsite role.Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.Main ResponsibilitiesLead, execute and support on-time completion of Quality Engineering deliverables from product concept through commercialization, including but not limited to risk management activities (RMF, FMEA, Cybersecurity Risk Assessment)Support on-time execution of Quality PlansGuide development and documentation of standard operating procedures, specifications and test proceduresSupport product recertificationsCAPA management – including (but not limited to) performing thorough investigations with detailed root-cause analyses with established methods (Fishbone, 5 Why), implementing corrections, corrective actions, creating and monitoring effectiveness criteria.Work within Agile software development lifecycle frameworkSupport usability and human factors engineering reviewsCoach and mentor team members on best practices in design quality, and overall product lifecycle testing/quality engineering to establish product and system reliability. Accent on agile testing and automated testing practicesParticipate in reviews for System and Software requirements, Software and Firmware design, and code inspectionReview and approve test methods, protocols and test results provided by another functional group.Support activities related to software change management and overall change managementBring forth ideas supporting continuous improvement and implement quality initiatives that measurably enhance medical device software and cybersecurity lifecycle activitiesSupport all activities, as needed by the business within the software development lifecycle.Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gapsSupport internal & external audit and related responsesSupport the establishment of objective, measurable and verifiable customer and product requirementsComplete document Change Request reviews in a timely and objective mannerAdditional duties may be identified by functional management based on the current project/business objectives.Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Perform other related duties and responsibilities, on occasion, as assigned.Education and Experience You'll BringRequired ExperienceBachelor level degree in Computer science, biomedical engineering, software engineering or a closely related discipline or an equivalent combination of education and work experience.Minimum of 2-5+ years of combined experience in software design quality, cybersecurity design qualityExperience ensuring automation frameworks and scripts meet design control requirementsExperience with software configuration, and issue tracking tools and requirements tools such as Jira and JamaExperience as team-member/lead in Agile SDLC projects/programsDeep knowledge of various types of SDLC's (V-Model, Iterative, Agile/Scrum, etc.)Experience working in a broader enterprise/cross-site business unit modelWorking knowledge of GMP, 21 CFR part 820, IEC 62304, ISO 14971, and ISO 13485Ability to work in a highly matrixed and geographically diverse business environment.Ability to work within a team and as an individual contributor in a fast-paced, changing environmentAbility to work in a lab, and hands-on experience with medical device developmentAbility to leverage and/or engage others to accomplish projectsStrong verbal and written communications with ability to effectively communicate at multiple levels in the organizationAbility to multitask, prioritize and meet deadlines in timely mannerStrong organizational and follow-up skills, as well as attention to detailPreferred ExperienceMaster's level degree preferredASQ CSQE and ISTQB certifications desiredExperience working with test management tools such TestComplete, desiredExperience in code review/static analysis tool(s) to aide code review such as Coverity, desiredProgramming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl, desiredClinical/Hospital experience desiredExperience in software testing and verification/validation, including lead experience, desiredThe base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.