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Senior R&D Engineer, Systems & Clinical

Company: Abbott Laboratories
Location: Plano
Posted on: January 11, 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 107,000 colleagues serve people in more than 160 countriesOur 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 R&D Systems & Clinical Engineer. The Engineer is expected to use his/her 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.--The Engineer is responsible for establishing data-driven customer, system and product requirements and validating customer requirements to ensure a high-quality patient outcome and for conveying the clinical value throughout the organization.--The 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, System Requirements, and Product Requirements* Assess and document clinical design risks and advise the team on risks and mitigations* Conduct preclinical studies and design iteration assessments of products both internally and with external key opinion leaders.* Design Validation Plans, Protocols & Reports. Develop, plan, execute, analyze and document experiments, and draw succinct conclusions.* 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* Organize and manage work to deliver usability deliverables on programs.* Prioritize tasks by distinguishing urgent from important tasks and assess 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 needs of users* Support Regulatory submission content, user manual (IFU) and training documentation (subject matter expert)* Maintain a detailed understanding of the developing clinical environment (i.e. 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, or Mechanical Engineering or related field.* 5+ years' experience in medical device related R&D.* Experience generating physician-based user needs. Experience writing system and product requirements and specifications and conducting testability assessments.* 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).* Self-starter needing minimal supervision. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.* Experience interfacing with a variety of management levels and effectively presenting technical information.Preferred * Advanced credentials in a relevant discipline/concentration, including Biomedical Engineering or medical field, preferred.* Fluency in surgical terminology and sound knowledge of anatomy and surgical technique.* Technical or medical experience in neuromodulation.* Technical or medical experience with DBS.* 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 communitiesLearn 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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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

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