Manufacturing Engineer II

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 LifeAs Manufacturing Engineer II, you will collaborate with all the necessary stakeholders on the assigned tasks and projects including counterparts in the US to ensure timely delivery. Responsibilities may include the following and other duties may be assigned: Prepare, review, revise, and maintain controlled Manufacturing Engineering documentation throughout the product lifecycle. Manage document control activities, including document creation, review, approval, release, revision, and archival within PLM, ERP, and Document Management Systems. Support Engineering Change Management (ECR/ECO/ECN/MCO) by preparing and implementing engineering change documentation. Maintain product configuration, manufacturing master data, and product attributes to ensure data accuracy and integrity. Prepare, review, revise, and maintain process risk management activities by maintaining PFMEA and other manufacturing risk assessment documentation. Ensure engineering documentation complies with QMS, Good Documentation Practices (GDP), ISO 13485, FDA/QMSR, MDR, and internal quality requirements. Collaborate with Manufacturing Engineering, Quality, Operations, Design Engineering, Regulatory Affairs, Supply Chain, and Facilities to support engineering deliverables. Coordinate cross-functional document reviews, approvals, and documentation status to ensure timely project execution. Support New Product Introduction (NPI), manufacturing transfer, process improvement, validation, and sustaining engineering projects. Prepare or review necessary validation plans, protocols, and procedures for successful completion of transfer activities. (IQ, OQ, PQ, MVP/MVR, SPC control, GRR). Through understanding of process validation procedures. Statistical tools, theories, analysis needed for process validation. CpK, Cp, Pp, PpK. Normal curve and other distributions. igma levels. Qualification pass/fail criteria. Design of MSA and understanding of statistical process involved. Attribute Agreement Analysis. Contribute to achieving Core Team goals & objectives and actively participate in Core Team meetings. Collaborate with Internal Manufacturing sites & supplier(s) to design, characterize and qualify high capability processes producing consistent finished products. This may include supporting process risk assessments (pFMEA), establish process flows, and develop control plans. PFMEA, RPN determination, RCA, FTA and other risk management and non-conformance analysis. Should maintain accountability and successfully deliver projects/tasks assigned. Must learn and ensure compliance with all GBU design control processes and procedures. Required Knowledge and Experience: Bachelor’s degree in mechanical OR production engineering OR equivalent with 6 to 8 years of experience in manufacturing and operations. 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. Prepare, review, revise, and maintain controlled Manufacturing Engineering documentation throughout the product lifecycle, (CP, Process sheets). Product Lifecycle Maintenance and Product Labeling Updates. Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification. Knowledge on GD&T & experience in interpreting mechanical drawings. Working understanding 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 including Value Stream Mapping, Line Balancing, FTQ, 8Wastes, 5S etc. 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 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). Good interpersonal skills and ability to independently handle projects with minimal supervision. Ability to manage/interact with suppliers and contract manufacturers. 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). 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 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. ‌ 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 & CompensationMedtronic 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).