Job Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Join Medtronic, a global leader in healthcare innovation, and bring your expertise to the forefront of ENT operations. As a Manufacturing Engineer II you will collaborate closely with all the necessary stakeholders on the assigned tasks and projects including your counterparts in the US to ensure timely and successful completion of the same, you will contribute to advancing ENT Ops solutions that make a real difference in patients lives. A Day in the Life As part of the Global Manufacturing Team at MEIC, your key responsibilities will be as follows: Key Responsibilities: Working with Stakeholders to set Manufacturing Process/ Transfer related deliverables. Supporting to designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling. Identify and communicate Operations and Program risks. Drive risk mitigation activity as necessary. Prepare or review necessary validation plans, protocols, and procedures for successful completion of transfer activities. (IQ, OQ, PQ, MVP/MVR, SPC-control, GRR, etc) Contribute to achieving Core Team/ Project team goals objectives and actively participate in Core Team/Project team meetings. Collaborate with Internal Mfg Sites supplier(s) to design, characterize and qualify high capability processes producing consistent finished products. This may include supporting process risk assessments (pFMEA), establishing process flows, developing control plans. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. May incorporate inspection and test requirements into the production plan. Should maintain accountability and successfully deliver projects/tasks assigned. Must learn and ensure compliance with all GBU-design control processes and procedures. Knowledge about ISO13485, ISO14971. Required Qualifications: Bachelor s degree in mechanical engineering with 5 to 8 years of relevant experience. Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification. Knowledge on GDT experience in interpreting mechanical drawings. Working understanding of statistics, including sample size selection, data distribution analysis, capability calculations, Design of Experiments (DOE), and Analysis of Variation. Strong Knowledge in Lean Manufacturing/ Six Sigma methodologies. Thorough knowledge and effective application of Design for Manufacturability, Design for Inspectability, Validation Protocol and Report creation, SPC, Process Control Plans, MSA, Gauging applications, design, and construction, Sampling methodologies, Data Analysis High degree of understanding/knowledge of Machining, Molding, Grinding, Forming, Assembly, Welding, Finishing, Cleaning, Passivating, Anodizing, Shot Peening, Mass Media Operations, Coatings, EDM, Casting, Forging, Polishing Good understanding on inspection methods and procedures. (Test Method validation TMV) Experience with risk-management, including but not limited to Process Failure Mode Effects Analysis (pFMEA), Design Failure Mode Effects Analysis (dFMEA), fault tree analysis, or other risk-management tools. Experience in FDA 21 CFR Part 820 Medical Device Manufacturing, or ISO 13485 is preferred. Knowledge on Engineering Change management processes and PLM-tools such as Agile, PTC Windchill is preferred. (Any PLM) Nice to Have: PLM and SAP Proficiency: Experience in product lifecycle management and working knowledge of SAP, particularly in tracking and transitioning product statuses. Six Sigma Certification: Certification in Six Sigma, Lean Manufacturing, or a similar process improvement methodology. Medical Device Experience: Prior experience with medical device manufacturing or decommissioning, along with familiarity with standards like DFMEA, PPAP, and FAI. Competencies: Medical device product development and/or manufacturing experience and a strong understanding of FDA, ICH and IEC-standards Experience across the entire product lifecycle. Experience working in a highly regulated industry (e.g. medical device, pharmaceutical, automotive) Experience with problem solving methodologies, manufacturing process validation. Project engineering or program management experience in a new product development and/or manufacturing environment Demonstrate strong problem-solving skills and the ability to ask critical questions without being the subject matter expert. Ensure structured problem methods and predictive engineering principles are consistently and rigorously applied, such as Design for Six Sigma, Lean Manufacturing, DFMA, DRM, FTQ or similar concepts. Physical Job Requirements: Mobility: This role requires independent mobility and regular interaction with computerized systems and project teams. Why Join Us: At Medtronic, you ll contribute to innovations that enhance healthcare outcomes and support the effective, safe decommissioning of medical products. Our Engineering and Innovation Center is dedicated to fostering growth, collaboration, and technical excellence. Be part of a team that pushes boundaries, supports personal development, and works toward Medtronic s mission of improving patient care and advancing technology. 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. 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. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here