Careers that Change Lives A Day in the Life Responsibilities may include the following and other duties may be assigned. Position Description Accountable for overall Engineering Program execution to include defining, designing, developing and delivering new medical device products or therapies to Medtronic customers. Using broad cross-functional knowledge and comprehensive business management skills, provides direction and leadership to a cross-functional program development team including members with expertise from the following disciplines: product development, clinical, regulatory affairs, quality, operations, product planning and product marketing. Monitors progress toward pre-established objectives, assesses risk and implements strategies to ensure successful delivery of the program. Secures resources for effective program development (people, capital). Deploys team resources to meet program objectives. Position Responsibilities Manages Engineering projects/activities of the assigned functions at MPROC level with responsibility for results in terms of alignment across business units, cost, methods, agility and efficiencies. Creates, develops and administers teams, budgets, schedules and performance standards according to MPROC and BU goals and priorities. Accomplishes results through inter-departmental teams. Provides recommendations of System Improvements pursuing full alignment within MPROC. Directly participates in establishing and administering multiple Engineering functional projects according to MPROC and BU goals and priorities. Acts as an advisor to team members to meet schedules or resolve technical or operational problems. Responsible for ensuring that project/activities results are aligned across MPROC and in compliance with the applicable regulations and Medtronic policies. Establishes communication forums and methods to report project progress against milestones. Works with MPROC partners to leverage from resources and methodology already in place. Establishes alliances and seeks benchmarking activities and programs within Medtronic BU's to be potentially used as MPROC models Evaluates cross BU initiatives and efforts in order to align proposals of improvements for all MPROC in light of our particular situation, needs and risks. Performs other related duties as assigned. Quality Responsibilities Reports any observed or informed process and/or product non-conformities to the Supervisor. Finds resolution of Quality Situations at the area of responsibility. Reports any complaint regarding a Medtronic product to the Supervisor. Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR's). EHS Responsibilities Ensure that EHS MS is effectively implemented and maintained within the area of operations. Provide visible demonstration of his/her commitment, including visiting and inspecting site, participating in incident/accident investigation, participation at EHS meetings and issuing messages of support. Provide adequate resources for the maintenance and corrective actions of the EHS. Participate in the definition of EHS objectives and targets for the area and ensure that they enhance continual improvement. Ensure the personnel are appropriately trained to carry out job activities in accordance to the EHS requirements, objectives and targets. Lead continual improvement projects to reduce, minimize or eliminate EHS aspects/impacts within his/her area of operations. Approve G & Os Define and periodical review of the organization's EHS policy. Ensure that the EHS Management System (EHS MS) is effectively implemented. Evaluate opportunities for EHS performance improvement and the overall enhancement of the EHS management system or any of its components. Perform periodical management review of the EHS MS to ensure its continuing suitability, adequacy and effectiveness. Minimum Education Bachelor Degree Basic Qualifications Background Educational: Engineering or related field Experience: o Manager Level: 7 Years with Bachelors or 5 Years with Masters Exposure to engineering and manufacturing environment Skills Teamwork Interpersonal Relations Quality and Results Oriented Computer Literate Fluency speaking and writing in English and Spanish Desired/ Preferred Qualifications Background Experience in medical device, pharmaceutical, or electronic industry Experience in the Qualification / Validation activities. Strong knowledge on GMPs (210/211 and 820), ISO 13485, and others (International std's), able to articulate and interpret regulations and its application in a manufacturing environment. Skills Analytical Thinking Problem Solving Presentation Project Management Communications Strategic Thinking About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future. Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America) SDL2017
