General coordination and administration of Advanced Engineering including project management, validations, manufacturing support, R&D support, continuous improvement initiatives.
Responsible for the formulation of objectives and other controls to meet business goals and regulatory guidelines. Recommends and implements policies and procedures within areas of responsibilities.
Manages capital project budgets. Manages the development, purchase and improvement of manufacturing equipment / processes and new product development as coordinated through corporate R&D.
Medtronic considers the safety of all employees to be of the highest priority. As such, it is the responsibility of each employee to treat safety in the same regard.
Strict adherence to established plant safety policies and procedures is expected of each employee. Unsafe conduct and failure to abide by plant safety procedures will result in appropriate disciplinary action.
As manufacturers of medical devices, every employee has the responsibility to ensure that we maintain the highest quality standards for our products.
Every employee is expected to understand and comply with 21 CFR Part 820 The FDA Quality System Regulation and Medtronic’s Medical Devices Guide to Compliance and Quality Manufacturing.
This along with the Quality System Regulations and the Quality System Standards provides the basic requirements for the design and production of medical devices.
Every employee is expected to understand and comply with Medtronic’s Guide to Business Conduct as well as those policies, practices and regulations that affect his or her job, and to report any violation.
Understanding the Guide to Business Conduct will create a culture of integrity that is an integral part of the way we do business.
ESSENTIAL FUNCTIONS :
Manage multiple projects, prioritization and leading the project engineering team to ensure Strategic project, transfers and key BU projects are managed appropriately and effectively to meet targeted deadlines and business expectations.
Provide support to production and corporate initiatives such as new product introductions and / or product and process improvements.
Ensure processes meet or exceed government requirements under FDA, OSHA, GMP, EPA, etc. Provide resources to reduce quality defects, to improve systems and controls, maintain and enhance a safe work environment.
Reduce costs of non-conformance; reduce customer complaints and potential loss to business. Identify safety hazards and take appropriate steps to control and / or eliminate.
Observe work areas regularly and initiate corrective action as required to meet safety policies, practices and compliance.
Ensure a safe working environment with the identification and correction safety issues.
Leads divisional improvement projects of significant size and scope as required
Drive strong project management skills and culture to project visibility and execution
Support to the Contract Manufacturing team in order to leverage the Renal Business CMs relationship.
Support and develop DRM methodology with R&D for project development related to the R&D organic pipeline and product ideation and prototyping.
Must be able to function in a team environment
Must be able to directly lead and / or co-lead high-impact process improvement projects.
Ability to manage multiple projects and leading high complexity projects.
Proven skills working with cross-functional teams
Presentation skills required
DEPARTMENT SPECIFIC / NON-ESSENTIAL FUNCTIONS : Support request of internal and external customers in a team base community.
Schedules, tracks, administer and controls expenses for assigned projects of various dollar values.
Bachelor’s degree in Engineering or related field. Master’s degree preferred.
Six or more years’ experience in a manufacturing environment related to process improvement and project management field with a demonstrated track record.
Previous experience in a medical device manufacturing environment with knowledge of FDA regulations is desirable. Experience with OSHA, HAZ-
COM, GMPS, and state / local government regulatory agencies are required.
Preferred Skills / Qualifications :
Strong verbal and written communication skills are critical including professional experience with : Group presentations, Technical reporting, analysis of facts and technical data, sound decision making, crisis management, value engineering and cost savings analysis
Skills / Competencies :
Creating / Managing Change, Goal Setting, Diversity Awareness, Communication and Prioritizing. Attention to Detail and problem solving techniques and tools
Other Skills :
Self-Directed, Self-Motivated, Multi-Task Orientated