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R&D Engineering Manager-Catheters

Company: Abbott Laboratories
Location: Irvine
Posted on: April 10, 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.Leading an active lifestyle is important to the many people we serve. In Abbott's Electrophysiology and Heart Failure (EPHF) division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies, allowing people to restore their health and get on with their lives. R&D Engineering (Product Development) Manager - Catheters As R&D Engineering Manager-Catheters, you will bring engineering leadership and best practices to lead and manage product and process development teams, focused on delivering our future catheters in support of Abbot's strategic plan. Located at our Irvine, CA site, be prepared to be bring your knowledge and experiences to drive strong technical and program level decision making in areas such as manufacturing or processing techniques, materials, properties and engineering project planning. Additionally, in this role, you will guide direct reports to select and use techniques to solve problems and make sound design recommendations. You will also provide leadership and mentoring to other engineers and technicians. Be prepared to be a hands-on participant as necessary on the prototype line, in the test lab, and preclinically. Job Duties:

  • Engage with R&D partners and other key internal and external development partners and stakeholders.
  • Communicate effectively both within R&D but cross-functionally as well to provide leadership in a matrixed organization.
  • Provide design/development teams with appropriate resources to perform assigned tasks.
  • Technical leader within the company.
  • Drive a culture of continuous improvement in development processes and tools
  • Formulate and implement research and development programs, policies, and procedures required to support profitable growth.
  • Interface with appropriate internal and external resources to ensure intellectual property is appropriately protected.
  • Interface with appropriate internal and external resources (regulatory, customers, etc.) to ensure development programs meet regulatory and customer requirements.
  • Provide technical assistance for diagnosing design and process development problems.
  • Keep senior management team informed of design/development progress and issues.
  • Guide development and documentation of test plan protocols, standard operating procedures, specifications and test procedures.
  • Provide input to departmental budget estimates for team headcount, materials, contractors and consultants.
  • Review and provide functional approval for project and quality system documentation.
  • Develop and manage organizational plans and resources for the specific department and business units for which they are responsible.
  • Provide mentorship and career development oversight for direct report employees.
  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Hire and retain a diverse, highly qualified staff and provides ongoing performance feedback. Set goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintain a safe and professional work environment.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Required Qualifications:
    • Bachelor's Degree in Mechanical, Biomedical, or related engineering discipline
    • 7+ years of experience in medical device development, including leading/managing a R&D team or a functional engineering team
    • Experience working in a highly matrixed and geographically diverse business environment.
    • Proven leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results
    • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
    • Ability to travel approximately 10%, including internationally. Preferred Qualifications:
      • Master's degree in a technical and/or business field
      • Management experience
      • Experience working in a broader enterprise/cross division business unit model
      • Solid Understanding of ISO 13485 and CFR 820.30 ABOUT ABBOTTAbbott 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 countries. 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: Follow 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

Keywords: Abbott Laboratories, Irvine , R&D Engineering Manager-Catheters, Executive , Irvine, California

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