Engineering Manager
MedTechPharmaRegulatory AffairsQuality Assurancegmpemafdaiso 13485croinform
Job description
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 not an exhaustive list of all the required responsibilities and skills of this position. 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. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com . Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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