Lead Manufacturing Engineer

Medtronic plc; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Medtronic plc is seeking a Lead Manufacturing Engineer to drive end-to-end manufacturing transfers, qualification, and optimization projects. You will collaborate with global units, suppliers, and quality teams to ensure successful program completion while upholding GMP standards.

The role focuses on complex transfer programs, process validation, and robust manufacturing readiness, leveraging your expertise in CAD, PPAP, and data-driven decision making.

Qualifications

• Bachelor’s or master’s degree in mechanical engineering or related discipline.
• 10 to 14 years of relevant experience in manufacturing engineering or regulated environments.
• Knowledge of GMP and 21 CFR Part 11.
• Experience with injection molding, stamping, and cleanroom manufacturing.
• Experience with DFMEA and PFMEA and risk management.
• PMP or equivalent project management experience.

Responsibilities

• Lead end-to-end execution of manufacturing transfer and optimization projects.
• Plan, schedule, and report project progress against quality, cost, and timeline commitments.
• Collaborate with global operating units, suppliers, sourcing, quality, regulatory, and engineering stakeholders to ensure timely project execution.
• Review and validate PPAP deliverables and manufacturability of engineering drawings.

Skills

Lean Six Sigma

Project planning

Stakeholder management

Process optimization

Change management

Education

Bachelor’s or Master’s degree in mechanical engineering

Tools

SolidWorks

Creo

Agile

Windchill

Power BI

Python

Job description

## Lead Manufacturing EngineerApplyremote type: Flexible Work Arrangementlocations: Nanakramguda, Hyderabad, Indiatime type: Full timeposted on: Posted Todayjob requisition id: R72455Careers 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 a Lead Manufacturing Engineer, you will collaborate closely with global operating units, suppliers, sourcing, quality, regulatory, and engineering teams to ensure timely and successful completion of assigned programs. This role will focus on medium- to high-complexity manufacturing transfers, supplier transfer programs, vertical integration, cost optimization, process qualification, PPAP execution, and manufacturing readiness. You will help strengthen supply reliability, improve cost competitiveness, and support the delivery of high-quality medical technology for patients around the world. You will be expected to lead technical discussions, resolve manufacturing challenges, apply data-driven engineering judgment, and model the Medtronic Mindset by acting boldly, moving with speed and decisiveness, fostering belonging, and delivering results the right way.**Responsibilities may include the following and other duties may be assigned:*** Lead end-to-end execution of manufacturing transfer, qualification, and optimization projects from scoping through implementation.* Plan, schedule, track, and report project progress against quality, cost, and timeline commitments.* Collaborate with global operating units, suppliers, sourcing, quality, regulatory, and engineering stakeholders to ensure timely project execution.* Identify risks, challenges, and constraints early and drive mitigation plans with cross-functional teams.* Facilitate supplier and cross-functional reviews to support alignment, decision-making, and project governance.* Manufacturing Engineering and Supplier Support* Provide technical support to suppliers by interpreting product drawings, reviewing manufacturing drawings, and resolving production-related technical issues.* Review and validate engineering drawings for manufacturability, accuracy, completeness, and alignment with applicable engineering standards.* Support manufacturing process development for injection molding, stamping, pressure die casting, cleanroom manufacturing, and related regulated manufacturing environments.* Drive the process improvement opportunities to strengthen manufacturing robustness, accelerate milestones, and improve decision-making.* Review and validate PPAP deliverables to confirm compliance with technical specifications and quality expectations.* Process Qualification and Validation* Lead or support process qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).* Develop, review, and approve Master Validation Plans, process flows, validation protocols, and related qualification documentation.* Apply medical device manufacturing standards, Good Manufacturing Practices (GMP), 21 CFR Part 11 expectations, and quality management requirements.* Ensure validation documentation and supporting artifacts are complete, compliant, and ready for stage-gate approvals.* Statistical Analysis and Measurement Systems* Use Minitab and statistical tools to perform process capability studies, including Cpk and related process performance analysis.* Conduct ANOVA, regression, criticality analysis, and data-driven studies to improve process reliability and quality.* Perform Measurement System Analysis, including GR&R studies, and identify appropriate MSA methods for process and inspection needs.* Use statistical evidence to support validation conclusions, supplier readiness, and manufacturing decision-making.* Risk Management and Compliance* Engineering Change Management* Partner with Quality during risk management activities and actively participate in design and process reviews, including DFMEA and PFMEA.* Identify risks impacting cost, quality, manufacturability, compliance, and schedule, and drive mitigation actions with suppliers and cross-functional teams.* Support engineering change management activities using PLM/PDM systems such as Agile and Windchill.* Maintain required compliance documentation and ensure technical artifacts support stage-gate reviews, change approvals, and quality requirements.**Required Knowledge and Experience**:* Bachelor’s or master’s degree in mechanical engineering, Production Engineering, or a related engineering discipline with 10 to 14 years of relevant experience in manufacturing engineering, supplier transfers, process validation, product sustenance, or regulated manufacturing environments.* Strong understanding of medical device manufacturing standards, GMP, 21 CFR Part 11 expectations, validation practices, and quality management systems.* Knowledge of manufacturing processes such as injection molding, stamping, pressure die casting, and cleanroom manufacturing setups.* Strong knowledge of DFMEA, PFMEA, risk management, root cause analysis, and corrective action practices.* Working knowledge of CAD tools such as SolidWorks or Creo and PLM/PDM systems such as Agile or Windchill.* DMAIC Or Lean Six Sigma Green Belt or Black Belt certification or demonstrated experience applying Lean Six Sigma methods.* Strong project planning, organization, communication, presentation, stakeholder management, influence management, and conflict resolution skills.* Experience in supplier transfer, vertical integration, localization, cost optimization, or value engineering programs.* Exposure should-costing, DFMA, aPriori, VAVE, SAVE/INVEST, or similar cost excellence methodologies.* Exposure to GD&T, tolerance stack-up and reverse engineering methods.* PMP training or certification or demonstrated experience managing cross-functional engineering projects.* Knowledge of Power BI, data analytics, Python, or automation tools for reporting, process tracking, and decision support.**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 [e-mail].# **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).### Who We AreWe 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.### What We Do**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### How We Are DifferentThese 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 careIt 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 [e-mail]