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 As 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
& 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). 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 R&D 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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com