1+ months
2018-03-152018-05-13

Principal Clinical Specialist

Abbott
Saint Paul, MN

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

We are seeking an electrophysiology (EP) lab experienced Principal Clinical Specialist to assist in development projects within the electrophysiology R&D systems engineering organization.  This position will provide clinical input to requirements development, risk assessment, verification, validation, and IFU development activities.  The ideal candidate would have an electrophysiology lab background and bring a clinical domain perspective to ablation, catheter, mapping & recording system, and other integrated device R&D activities.  This role impacts early product development, system behavior, and includes engaging in a consultative capacity on user workflow/user interface design.  Activities include influencing system definition through translation of customer needs into product requirements and system-level verification and validation planning. 

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Impact this role will have on Abbott:

  • Primary clinical input on development of new features/functionality/products and upgrades
  • Contribute to product requirements, design activities, verification and validation planning
  • Part of cross-functional project teams
  • Lead/support pre-clinical and clinical evaluations
  • Provide clinical workflow input to reflect the current understanding of electrophysiology lab practices in the customer base
  • Contribute clinical perspective to ongoing R&D product development: requirements, product and test designs, defect reviews, user workflows, and field complaint investigations
  • Perform clinical readiness assessment of animal/pre-clinical study devices
  • Coordinate user/validation testing and support clinical testing for new features/functionality
  • Design and implement a domain-specific cross-training program for the R&D team incorporating such topics as basic electrophysiology, lab procedures & equipment, and field study review
  • Assist with transfer to manufacturing procedures, review documentation of importance to field clinical personnel, and amplify the voice of field clinical engineers/technical service/training & education
  • Product expertise should go beyond features and benefits, focusing also on design, development, clinical application, and competitive positioning
  • Remain current with clinical knowledge and practice – maintain expert status, and continuing clinical and technical proficiency, in cardiac rhythm management and electrophysiology
  • Occasional interface with field personnel and practitioners potentially including key opinion leaders while supporting global roll-out/focused study/troubleshooting activities (partnering with clinical, marketing, pre-clinical, technical support, and training/education teams)
  • Support process improvements within the R&D organization

    Your experience(s), education, and knowledge will further expand Abbott’s marketplace success:

    • Seven plus years of relevant clinical experience in electrophysiology
    • Experience with electrophysiology procedures, ablation procedures, cardiac mapping and recording techniques
    • Evaluation, originality, and/or ingenuity
    • Polished written and verbal communication, interpersonal, facilitation, and presentation skills
    • Experienced in quantitative, analytical, organizational, and follow-up skills
    • Proven ability to meet project/ product deadlines
    • Effectively engage in conversations with all levels of employees, management, and customers
    • Excellent documentation skills in delivering information that adds value to management's decision making process
    • Strong technical skill set including spreadsheet, word processing, PowerPoint, and specialized applications
    • Experience working in the medical device industry or other highly regulated industry
    • Ability to understand and comply with applicable FDA regulations and company operating procedures, processes, policies and tasks

      Your preferred qualifications and education:

      • An advanced credential in a relevant discipline/concentration such as biological sciences/biomedical engineering degree
      • Professional Health Science certification or engineering
      • Successful completion of current International Board of Heart Rhythm Examiners (IBHRE) competency certification in the fields of cardiac rhythm device therapy and cardiac electrophysiology for physicians and allied professionals
      • Successful completion of legacy IBHRE North American Society of Pacing and Electrophysiology (NAPSE) NASPExAM
      • Ability to travel, including internationally

        NOTE: Relocation package available
        Job Family: Research and Discovery
        Division: ASJM Abbott St. Jude Medical
        Travel: Yes, 10 % of the Time
        Medical Surveillance: Not Applicable
        Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Principal Clinical Specialist

Abbott
Saint Paul, MN

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Abbott
Saint Paul, MN
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