Specialist, Clinical and Project Lead

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.

A healthy heart is essential to good health. That’s why we’re committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people’s health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. 

We are seeking an experienced, high caliber Specialist Lead, Clinical Group for our Sylmar, CA location. A scientific professional who, working with little or no supervision, applies process and project management knowledge, engineering knowledge and ingenuity to complete medium size projects from concept thru project closure, across disciplines and locations in the complaint handling post market process

WHAT YOU’LL DO

Leads and coordinates high severity/unusual/new product complaint processing and escalation across multiple locations and internal/external stakeholders. Applies clinical insights and product understanding to inform regulatory guidance documents and SOPs. Develops, plans, coordinates and directs post market aspects of projects such a s new product launches, post market regulatory changes, post market efficiency programs across multiple locations that are of major scope and importance. Manages multiple, often concurrent projects and meets expectations. Makes difficult decisions regarding priorities among projects. Understands the business needs and has a thorough knowledge of the customer when developing a project scope.

RESPONSIBILITIES :

• A Subject Matter Expert in complaints process. Participates on internal, cross-divisional teams to develop and align procedures and standards. Participates on group or divisional task forces. Performs tasks, such as writing SOP/DWI updates, safety / quality checklists,, position papers etc. Anticipates and resolves problems and crisis situations requiring fast, astute decisions with rapid implementation by utilizing technical training and / or experience. Assists in the development and execution of validation protocols. Participates in professional affiliations.

• Incorporates business foresight of emerging regulatory and technological trends.

• Supports development of project strategy to align and achieve key customer business objectives. Contributes to the development of long-term business and organizational strategies.

• Establishes Quality/Compliance project objectives and scientific criteria for evaluating project results and activities of the project team. Develops project plan documenting the actions necessary to define, prepare, integrate and coordinate all subsidiary plans.

• Directs and manages Project and Task Execution by performing the work defined in the project plan to achieve project objectives.

• Closes the project by finalizing all activities across all the Project Management Process Groups to formally complete the project or phase. Monitors and controls project work to meet the performance objectives defined in the project plan.

• Focuses on cost and milestone achievement to optimize resource utilization.

• Reviews change requests, manages and approves changes to the deliverables, organizational process assets, project documents, and the project plan.

• Anticipates and identifies areas of risk and mitigates risks through early risk assessments and implementation of fallback / mitigation strategies.

TECHNICAL / DESIGN:

• Directs others in the execution of the design of complaints processes/ processes /systems / facilities by applying scientific methods, concepts and techniques. Ensures the complaints process complies with all regulatory standards, project objectives and customer needs. Benchmarks with other divisions as needed. Works with customer on project approach / design to optimize asset value.

PROBLEM SOLVING / INNOVATION:

• Conceptualizes complete solutions. Creates or coordinates the solutions for complex problems. integrates regulatory and operational needs. Reviews constructability strategy. Performs cost / benefit analysis. Explores multiple alternatives. Leads cross functional teams in resolving major project hurdles.

ORGANIZATIONAL INTERFACE:

• Mentors others by sharing knowledge and expertise and providing feedback and guidance. Anticipates, identifies and implements ways to increase customer satisfaction. Establishes relationships and good communication channels with customers. documents agreements and commitments. Prepares written communication. Conveys information effectively through formal and informal documents with team members, designers, technicians, and other personnel, both internal and external to Abbott, using appropriate communication protocols. Exhibits advanced ability to apply concepts of careful communication. Establishes networks. Contributes willingly and incorporates the ideas of others. shares resources, knowledge and accountability to benefit the objectives of the business. Builds relationships. Initiates and cultivates open, honest relationships with colleagues, customers, contractors, and vendors by establishing rapport, developing an understanding of others’ needs, promoting common goals, and following through on commitments. Acts as a trusted advisor. Balances bottom line objectives of a project with the long-term interest of customer.

COMPLIANCE:

• Complies with all regulations and standards for quality, Environmental, Health, Safety, and Energy (EHS&E) Global Policies, Abbott Quality Standards, and other governance areas as applicable. Ensures quality and effectiveness of assigned tasks and key project results through sound design and project management processes. Has full awareness of the potential consequences (defects and failure modes) of design changes.

EDUCATION AND EXPERIENCE YOU’LL BRING  

EDUCATION

Bachelors Degree (± 16 years)

Engineering, science, or closely related discipline

OR an equivalent combination of education and work experience

Masters Degree (± 18 years) Desired

EXPERIENCE

Minimum 10 years

Significant clinical/engineering and / or operational experience.

A career history marked by a consistent series of contributions and accomplishments. Demonstrated excellence in breadth and depth of knowledge within post market regulations, process and some background on project coordination/management.

Proven track record of managing projects to completion, using extensive external resources.

Interacts well with diverse groups and maintains strong working relationships with internal and external collaborators.

Listens to and understands others’ points of view and articulates tactfully and respectfully one’s own perspective orally, in writing, and in presentations.

Works well with other engineers in a collaborative, fast-paced goal-driven environment.

Possesses interpersonal skills to negotiate and reconcile differences.

A clinical or technical background in health care, laboratory diagnostics, medical devices, pharmaceutical (preferred). Understanding of CRM products is desired.