Manager, ICD Device Analysis & Reliability Lab at Abbott

Expires in 14 days

United States - California - Sunnyvale
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.

  • Essential Functions:
    1. Responsible for hiring and retaining a diverse, highly qualified staff and for providing career coaching, growth, and personal development. Accountable for the staff development; critiques, instructs, mentors, evaluates, and coaches. Accountable for the
    performance of subordinates and work output of managed subcontractors. Maintains a safe work environment and a strong
    customer focus. Sets goals, ensures that they are met and is responsible for continuous process improvement.
    2. Manages the Reliability Laboratory. Analyzes failure trends, develops and implements investigative protocols to identify root
    causes. Presents findings to the review boards when necessary, and requests corrective action to reduce further
    occurrences.
    3. Works with Research and Development (R&D) to resolve reliability issues and monitors resulting corrective action.
    4. Manages Returned Device Analysis function that analyzes ICD devices and miscellaneous accessories.
    5. Prioritizes work including Service Requests; monitors progress, evaluates problems and develops resolutions, particularly in
    regard to the allocation of resources.
    6. Reviews all Product Analyses, approving closure of files which meet company and regulatory requirements.
    7. Supports Technical Services/Quality/Operations/Clinical/Legal by answering technical questions concerning electrical/mechanical aspects of devices, status of particular tests, etc.
    8. Operates Scanning Electron Microscope and Energy Dispersive Spectrophotometer for the more complex investigations.
    9. Ensures compliance with regulatory requirements related to returns with complaints.

    Other Duties:

    1. Remains current on developments in field(s) of expertise, regulatory requirements, and a comprehensive knowledge of the
    company's products, markets, and objectives as well as industry trends.
    2. Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
    3. Performs related functions and responsibilities, on occasion, as assigned.
    4. Participates in internal/external audits as required in SME role

    Accountability/Supervision:

    Work is performed within broad objectives. Has authority to make resource, schedule and performance commitments for assigned efforts and is accountable for results; develops/implements reliability, product return analysis policies and procedures and sets goals, priorities and systems that affect the future direction of failure analysis at CRMD. Provides substantial input to CRMD-wide engineering, quality assurance and/or divisional standards, practices, procedures and policies. As the leader and key contributor to the PIB, ensures proper product issue evaluations and closures. Responsible for long-term and organizational planning. Fully accountable to customers and executive management for timely and accurate product
    return analysis. Acts as mentor to Supervisors and other Managers to develop solutions and resolve complex problems that could significantly impact organization budgets or commitments. Resolves complex problems and develops original solutions. Decisions and recommendations have critical impact on significant organizational projects or operations.

    Relationships:

    Internal: Accomplishes results through direct staff, line managers and teams. Sets the strategic direction for the organization, focusing on customer satisfaction and continuous process improvement. Represents the organizational unit as the prime customer contact on organization operations. Interfaces with all levels of management in each functional department. Provides guidance and support to legal, customer service, development & operation functions on a routine basis. Participates in and approves staffing and organizational structure. Ensures the development of high performance teams and effective working relationships with other organizations. Provides leadership for the development of employee competencies and recommends goals and priorities for the organization. Provides an overall environment that facilitates employee development, growth and performance. Conducts briefings for top management. Supports peer reviews.
    External: Serves as the principal spokesperson for CRMD in matters of high significance within the area managed. Interfaces with Regulatory Compliance and Global Regulatory Agencies.

    Equipment:

    Microsoft Office Suite. Works with a computer, specialized software; various document production machines and equipment, such as high speed and color copiers, collators, binding machines and power staplers, punches, etc, and a variety of standard office equipment, such as telephone, fax, pen pencil, markers, etc. May also work with projectors, pointers, etc., when making presentations.

    Working Conditions:

    Works in an air-conditioned, well-lighted office. Generally moderate noise level, but noise can be at somewhat higher levels due to reproduction equipment and personal inquiries from customers and suppliers.
    Physical Demands: Describe the physical demands representative of those that must be met by an employee to
    Significant amount of time sitting at desk and/or in front of computer monitor. Some walking and standing, particularly when using office, and on rare occasions, reprographic equipment (trouble-shooting, instruction, etc). Requires ability to reach with hands and arms, and manual dexterity to use keyboard, telephone, and other equipment. Good hand/eye coordination to operate computer and other equipment. Ability to lift and/or carry up to approximately 25 pounds on occasion.

    Qualifications:

    Required: A Bachelor's Degree in Engineering, Science, a related field or equivalent; typically ten plus years of progressively more responsible work experience in high technology manufacturing is required. Requires highly developed leadership
    skills/experience sufficient to assume the responsibilities of this management position. Must be skilled at delegation, follow-up, database management tools, document control procedures, and team building. Demonstrated verbal and
    written analytical/problem solving, communication, negotiation, interpersonal and presentation skills are essential. Demonstrated personal computer skills including spreadsheet, word processing, data base management and other
    relevant applications.
    Desired: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Previous experience in failure analysis as well as seasoned judgment acquired through organizational experience in the medical
    device industry is highly desirable.
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