Director R&D Program Management

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

WHAT YOU’LL DO 

You will be responsible and accountable for the overall Business Unit (B/U) R&D portfolio, including research & technology (R&T), new product development (NPD) and product lifecycle management sustaining activities (sustaining), within the Research and Development Organization.  You will provide critical leadership and decision-making responsibility to the program management office and the cross-functional project teams regarding design control, milestone tracking and delivery, risk management and escalation, regular executive leadership review, product launch readiness, etc., and guide the teams to execute and deliver critical NPD launches on time, within budget and with quality. You will work closely with cross-functional peers in quality, operation, marketing, clinical and regulatory, medical affairs, commercials to define an aligned and predictable NPD roadmap and team up to own and drive the delivery of the roadmap with critical decision-making responsibility.

Job Duties:

• Cross-functional Portfolio Leader within the business division.
• Manages all key new product development projects within the B/U.
• Assures the development of multi-level project planning to achieve short and long-term business objectives.
• Provides critical leadership to the cross-functional design/development teams to stay focused.
• Develops, tracks, and reports on all key product development and technology development programs.
• Keeps senior management team informed of design/development progress, risks, and issues.
• Formulates and implements programs, policies, and procedures required to support engineering needs; drive process efficiency and productivity where make sense.
• Develops functional departmental budgets and coordinates cross-functional project budgets.
• Develops and communicates key performance indicators (cost/schedule/technical/quality) for projects.
• Provides design/development teams with appropriate resources to perform assigned tasks.
• Interfaces with appropriate internal and external resources to ensure intellectual property is appropriately protected.
• Interfaces with appropriate internal and external resources (regulatory, customers, etc.) to ensure development programs meet regulatory and customer requirements.
• Guides development and documentation of test plan protocols, standard operating procedures, specifications and test procedures.
• Contributes to business unit operational and strategic planning.
• Participates in review boards for CAPA, complaints, business unit planning, and others as necessary.
• Reviews and provides functional approval for project and quality system documentation.
• Evaluates potential business partners, including physicians, vendors, contract product development and manufacturing companies.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
• Provides mentorship and career development oversight for direct report employees.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION AND EXPERIENCE YOU’LL BRING 

Required 

• Minimal four-year BS degree in an engineering field – biomedical, mechanical, electrical, computer engineering, physics, materials science, biochemistry.
• MSc or Ph.D. in an engineering field, or MBA, is preferred.
• Excellent verbal and written communications with exceptional influence at multiple levels in the organization.
• Minimum of ten (10) years’ experience in medical device development and/or other highly regulated industry
• Previous experience leading/managing an R&D, Program Management, or equivalent engineering function.
• Experience working in a br