Engineering Manager

Careers that Change Lives

Role in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

A Day in the Life

Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified areaThe majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports.

Must Have

Job Responsibilities

·Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.

·Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.

·Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.

·Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

·Provide leadership to a team that handles complaints

·Evaluate strategy to transform operations and look for continous improvements

·Evaluates incoming complaint information and maintains the record in the electronic database.

·Performs follow up activities to obtain additional information.  Use and maintain database(s), provide analysis and trending data all on complaints.

·Determines Reportability of complaints to Government Agencies.

·Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.

·Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.

·Interacts with multiple departments within Medtronic - MITG, such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering.

·Interacts with groups external to such as customers, vendors, health care professional

Minimum Qualifications

·Bachelor degree; Engineering or Science degrees preferred (e.g. SW,EE, ME, Biomedical Engineering)

·15+ years quality assurance or regulatory experience in medical or pharmaceutical industry.

·Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis

·Strong typing skills and ability to write business documents with minimal supervision.

·Strong verbal and written communication skills and ability to work in a team oriented environment

·Ability to be proactive and lead initiatives technically

·Ability to multitask.

·Ability to understand the functionality / intended use of complex medical devices.

·Minimum travel may be required 

DIFFERENTIATING FACTORS

·Autonomy: Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments.

·Provides tactical and / or operational leadership and coaching.

·Receives assignments in task and objective oriented terms.

·Organizational Impact: Establishes operational plans and implements policies and strategies.

·Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds.

·May have budget or P&L accountability for a department, function or geography.

·Strive for continuous improvement and consistency in deliverables.

·Innovation and Complexity: Proposes modifications to functional operating policies and day-to-day processes.

·Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.

·Communication and Influence: Communicates with internal and external customers and vendors regarding ongoing operations.

·Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties .

·May interact on issues that have externally shared objectives.

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