Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life The Engineering Manager, Manufacturing leads manufacturing engineering functions supporting the development, validation, implementation, and continuous improvement of production processes. This role is accountable for process robustness, equipment performance, automation projects, product transfers, process validations (IQ/OQ/PQ), and compliance with FDA, GMP, and ISO 13485 requirements.
The Engineering Manager drives Lean Manufacturing and Six Sigma initiatives, supports CAPA and nonconformance investigations, and ensures manufacturing systems are optimized to achieve quality, productivity, and cost objectives while maintaining regulatory compliance and operational excellence. Responsibilities may include the following and other duties may be assigned. Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products. Oversees the investigation and evaluation of existing technologies. Guides the conceptualization of new methodologies, materials, machines, processes or products. Directs the development of new concepts from initial design to market release.
Manages feasibility studies of the design to determine if capable of functioning as intended. Monitors documentation maintenance throughout all phases of research and development. Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Must Have: Minimum Requirements: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization. Requires a bachelor’s degree in engineering and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience. Requires a bachelor’s degree in engineering and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.
Required Skills: Manufacturing Engineering leadership within a regulated manufacturing environment. Expertise in Lean Manufacturing, Six Sigma, and continuous improvement methodologies. Experience with process validations (IQ/OQ/PQ), equipment qualification, and technology transfers. Strong knowledge of FDA regulations, GMP, ISO 13485, CAPA, and Quality Systems. Proficiency in root cause analysis, SPC, FMEA, DOE, and process optimization tools.
Experience leading automation, productivity improvement, and cost reduction initiatives. Proven ability to manage engineering teams and cross-functional projects. Strong project management, communication, and stakeholder management skills. Ability to support manufacturing operations while driving quality, efficiency, and compliance objectives. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R.
§ 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are