Senior Compliance Engineer

Job ID: Posted: Posted 28 Days AgoStart Date: Location: United States - Texas - Plano, United States of AmericaTime Type: Full timeAbbott 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 122,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:Job TitleSenior Compliance EngineerWorking 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 you dream of.Employees can qualify for 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 contribution.Tuition 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.What You’ll Work OnThis position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.The Senior Compliance Engineer is responsible for ensuring Abbott Neuromodulation products comply with applicable medical device safety, EMC, wireless, environmental, and other regulatory standards throughout the product lifecycle. This role provides technical leadership in product compliance strategy, standards interpretation, testing, and impact assessments while collaborating closely with product development teams, external test laboratories, quality, regulatory, and manufacturing organizations to deliver safe and compliant medical device solutions.Serves as a technical lead and subject matter expert for product compliance activities across new product development and sustaining engineering projectsEvaluates product designs against applicable national and international standards, including electrical safety, electromagnetic compatibility (EMC), wireless, environmental, and medical device-specific requirementsDevelops compliance strategies, test plans, protocols, and reports to support product verification, validation, regulatory submissions, and market access activitiesCollaborates closely with systems, electrical, firmware, mechanical, quality, regulatory, and manufacturing teams to ensure compliance requirements are incorporated throughout the design and development processPartners with external test laboratories, certification bodies, and regulatory organizations to plan, execute, and successfully complete compliance testing and product certificationsConducts impact assessments for product changes, component substitutions, manufacturing changes, and design modifications to determine compliance implications and required testingMonitors revisions to applicable standards and regulations, evaluates their impact on existing and future products, and develops implementation plans to maintain complianceInvestigates compliance-related issues, supports root cause analysis activities, and develops corrective actions to address identified gaps or nonconformancesEffectively communicates compliance requirements, risks, testing results, and recommendations across all levels of the organization to support informed decision-making and successful product developmentMinium QualificationsBachelor’s degree in Electrical Engineering or related engineering disciplineMinimum 5 years of experience in product compliance, electrical engineering, or a related fieldExperience interpreting and applying technical standards and regulatory requirements to electronic productsExperience developing and executing compliance testing programs, including test plans, protocols, and reportsExperience working with external test laboratories and certification organizationsExperience performing engineering assessments, risk evaluations, and impact analyses for product or process changesExperience working in a regulated product development environmentStrong analytical, problem-solving, technical writing, and communication skillsPreferred Qualifications7+ years of experience supporting compliance activities for complex electronic or medical device productsExperience with Class II or Class III medical devices.Strong knowledge of medical device standards, including IEC 60601 series, ISO 14708 series, IEC 62304, ISO 10993, IEC 60601-1-2, FCC, RED, and other applicable regulatory requirementsExperience supporting implantable, externally worn, or wireless medical device systemsExperience conducting EMC, electrical safety, environmental, reliability, and wireless compliance evaluationsExperience assessing the impact of standards revisions and regulatory changes on existing product portfoliosExperience working with cross-functional product development teams throughout the product lifecycleApply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at and on Twitter @AbbottNews.The base pay for this position is $78,000.00 – $156,000.00In specific locations, the pay range may vary from the range posted.JOB FAMILY:Product DevelopmentDIVISION:NM NeuromodulationLOCATION:United States > Texas > Plano : 6901 Preston RoadADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Not specifiedMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time 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: is the Law link - Espanol: