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Senior R&D Engineer, Clinical

Company: Abbott Laboratories
Location: Plano
Posted on: November 22, 2021

Job Description:

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 within R&D for a Senior Clinical Engineer. The Clinical Engineer uses in-depth knowledge of anatomy and biomechanics to work with design engineers and clinicians to develop safe and highly effective new products and upgrades to existing products for our neuromodulation systems platform. The Engineer is responsible for establishing data-driven customer requirements, validating customer requirements to ensure a high-quality patient outcome, and conveying the clinical value throughout the organization, including demonstrating that products meet their intended use within their use environment. The Clinical Engineer is also responsible for leading risk assessment activities as well as usability initiatives across product/organizational lines. WHAT YOU'LL DO

  • Develop Customer Requirements Documents and support development of System Requirements Documents and Product Requirement Documents.
  • Assess and document clinical design risks and advise the team on risks and mitigations.
  • Develop, plan, execute, analyze and document experiments, and draw relevant conclusions.
  • Develop Design Validation Plans, Protocols & Reports. Conduct preclinical validations and design iteration assessments of products both internally and with external key opinion leaders.
  • Conduct formal validation testing for new products, product updates, and modifications to existing designs, to ensure the clinical safety and efficacy of the product.
  • Develop/modify clinical workflows and facilitate the transition of new/updated technology and features into products through clinical review and evaluation.
  • Leverage clinical and product expertise to aid new concept and product development and evaluate compatibility of system components in clinical workflow scenarios.
  • Plan and conduct worldwide customer, competitive, and software industry research to identify and prioritize usability improvement possibilities and solutions.
  • Organize and manage work to deliver usability deliverables on programs.
  • Prioritize tasks by distinguishing urgent from important tasks and assesses cost/benefit trade-offs.
  • Develop understanding of the scientific, technical, medical, and clinical aspects of Abbott neuromodulation devices and features and the disease states they aim to treat.
  • Support clinical evaluation of new or enhanced products. Identify potential product enhancements and new product ideas by applying an analytical approach to understanding the clinical needs of physicians.
  • Maintain a detailed understanding of the developing clinical environment (e.g. current treatment methods, evolving clinical needs, etc.).
  • Maintain a detailed understanding of Abbott, FDA 21 CFR Part 820, and ISO regulations. EDUCATION AND EXPERIENCE YOU---LL BRINGRequired
    • Bachelor---s degree in Biomedical Engineering/Mechanical Engineering/Electrical Engineering/related engineering field or an equivalent combination of education and experience.
    • Minimum 6 years relevant, progressively more responsible work experience in medical product development and/or a graduate degree with relevant project experience.
    • Demonstrated ability to apply an expert understanding of clinical application to issues in order to bring tasks to resolution within assigned projects. Demonstrated ability toeffectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required.
    • Self-starter needing minimal supervision. Strong verbal and written communications with the ability to effectively communicate at multiple levels within the organization.
    • Experience interfacing with a variety of management levels and effectively presenting technical information.
    • Ability 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, changingenvironment. Ability to leverage and/or engage others to accomplish projects. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Preferred
      • Experience gathering user needs and defining customer requirements.
      • Experience generating data-driven justifications for requirements, including designing and executing testing needed to support clinical justifications.
      • Experience working on teams to design devices that meet user needs.
      • Experience designing and leading preclinical device studies.
      • Experience leading technical reviews.
      • Experience working with physicians in a clinical environment (OR, ASC, in-office).
      • Advanced credentials in a relevant discipline/concentration, including Biomedical Engineering or medical field.
      • Experience with Matlab, Simulink, or equivalent.
      • Fluent in surgical terminology and sound knowledge of anatomy and surgical techniques.
      • Technical or medical experience in neuromodulation.
      • Technical or medical experience with Spinal Anatomy.
      • Experience supporting physician visits.
      • Experience supporting clinical testing of devices. WHAT WE OFFER At 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 Learn more about our benefits that add real value to your life to help you live fully:-- www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at, on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

Keywords: Abbott Laboratories, Plano , Senior R&D Engineer, Clinical, Engineering , Plano, Texas

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