Total 1 job vacancies by 2129 Abbott Rapid DX

JOB DESCRIPTION:

About Abbott:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. For more than 125 years, we've brought new products and technologies to the world and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Today our 107,000 colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve.

Responsibilities and Duties:

Reporting to the Science and Technical Operations Director for Rapid Diagnostics (global markets), the Senior Manager will be an engineering/science professional, responsible for leading technical projects (e.g. product development and sustaining engineering) through a matrix of cross-functional groups. 

Your primary responsibility for this role is to manage the technical and scientific development of new and existing projects. You will have responsibility for overseeing and approving design inputs and managing/reporting the technical status of development projects from our global sites. The role is expected to establish the development strategy, oversee design reviews, and become the technical “go-to” person for our lateral flow platforms.

Additionally, you will ensure appropriate technical development timelines whilst achieving other design excellence metrics for on-market product development and Life Cycle Management activities. You will advance platform development and drive existing product support through interactions with Commercial, R&D, Regulatory, Quality, Medical Affairs and other key business stakeholders.  

You will provide direct technical and organizational leadership to the Science and Technical Operations organization, ensuring a culture of sustaining, as well as driving the design for manufacturability and reliability. You will also work with Quality, R&D and Operations to ensure that processes are in place for all design lifecycle activities. 

Requirements:

• Provides technical leadership and centralized technical oversight for the R&D organization in the planning, development and execution of technical projects to achieve critical strategic business objectives.
• Manages multiple technical projects concurrently to ensure critical path technical challenges do not impact or minimize schedule impact.
• Competent in making difficult technical decisions regarding priorities among projects/programs while ensuring the buy-in of teams and leaders
• Provide technical leadership and clear direction to the R&D Engineering organization across multiple sites.
• Create and deploy development strategies while providing tactical leadership for medical device innovation and product support programs.
• Ensure a culture of innovation becomes second nature
• Technical leadership of engineering R&D managers, principal engineers and the technical direction for all medical device development. Directly accountable/responsible for the technical deliverables of the R&D function.
• Responsible for management and clear communication of NPD (New Product Development) project portfolio for R&D engineering, including development of appropriate metrics for tracking and supporting continuous improvement efforts, e.g. design excellence.
• Lead Engineering Excellence in all we do across the R&D Engineering group
• Create and maintain development standards, training programs and operating procedures that ensure all development activities meet regulatory guidelines and comply with the Quality System.
• Ensure through technical direction that program milestones are achieved.
• Create and manage design inputs (user needs / VOC/ etc.) program working collaboratively with Commercial, Marketing, Medical Affairs, Regulatory, Customer Care and other stakeholders.
• Drive a robust CAPA process through the establishment of guidelines, operating principles, procedures and training curriculums.  The guidelines should foster a design for six-sigma culture, driving design for manufacturing and data driven design for reliability.
• Develop and maintain relationships with third level institutions, engineering test labs, key suppliers and appropriate consulting work providers.
• Collaborate closely with functional areas such as Quality, Manufacturing and Regulatory to support external audits and certification activities. This includes preparation as well as response to the audit findings.

Education & Experience:

• BS/MS / B Eng degree in any of the following disciplines Science / Biologics / Bio Med / Engineering
• Strong technical background in device and assay development considered
• 15+ years of assay development and biologics essential
  • Additionally experience in medical device development is considered a plus
• 10+ years leadership experience and functional management required
• Excellent problem solving methodology, using industry accepted concepts and tools to solve complex technical problems in creative and effective ways as they apply to compliance issue

Leadership Characteristics: Making Complex Decisions

• Complex problem solving and decision-making based upon the available data.
• Leverages personal experience
• Uses multiple problem solving tools as required to drive to a solution
• Open and collaborative style

Communicating Effectively

• Writes and presents effectively; adjusts to fit the audience and the message; strongly gets a message across

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: