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Manufacturing Engr II

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Medtronic

Jan 9, 2025

  • Job
    Full-time
    Senior Level
  • Engineering
  • Hyderabad
  • Quick Apply

AI generated summary

  • You need a degree in mechanical or industrial engineering, 6-8 years of relevant experience, proficiency in CAD and SAP, Six Sigma certification, and strong compliance knowledge in medical devices.
  • You will optimize decommissioning processes, collaborate with teams, manage ECOs, ensure compliance, track status, verify demands, and maintain accurate documentation within PLM frameworks.

Requirements

  • Education: Bachelor’s degree in mechanical engineering, Industrial Engineering, or related field.
  • Experience: 6 – 8 years of relevant engineering experience with a focus on PLM processes, decommissioning, or lifecycle management in a regulated industry. Familiarity with SAP and ECOs is required.
  • Technical Skills: Proficiency in CAD software (e.g., SolidWorks, Creo), data management systems like Windchill, and PLM platforms.
  • Analytical Skills: Strong understanding of Design for Manufacturing (DFM), tolerance stack-up analysis, and statistical analysis methodologies (e.g., DOE).
  • Compliance Knowledge: Solid understanding of regulatory compliance, including ISO 13485, FDA regulations, and medical device standards.
  • 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.
  • Project Management: Ability to manage and prioritize multiple decommissioning projects, ensuring timelines and deliverables are met.
  • Communication and Teamwork: Strong verbal and written communication skills with a proven ability to collaborate across teams and present technical findings effectively.
  • Problem-Solving: Structured approach to identifying, analyzing, and resolving engineering challenges, with a proactive mindset toward continuous improvement.
  • Mobility: This role requires independent mobility and regular interaction with computerized systems and project teams.

Responsibilities

  • Design and Process Optimization: Develop, maintain, and optimize processes related to product decommissioning within the PLM framework, ensuring compliance with industry standards like ISO 13485 and FDA 21 CFR Part 820.
  • Collaborative Support: Work closely with internal teams, suppliers, and cross-functional stakeholders to streamline phase out initiatives and ensure alignment with ENT Operating Unit goals.
  • Documentation and ECO Development: Prepare Engineering Change Orders, validate processes, and ensure meticulous documentation to support PLM processes in ENT Operations.
  • Technical Insight and Troubleshooting: Provide technical support and resolve issues within the decommissioning process, applying engineering principles and PLM expertise.
  • Data and Status Management: Track, review, and report on decommissioning status and PLM activities, supporting timely closeouts and documentation accuracy.
  • Regulatory Compliance and Risk Mitigation: Ensure all procedures comply with regulatory standards, utilizing tools like pFMEA for risk management.
  • Final Demand Verification: Analyze and verify final demand requirements post-shipment to confirm readiness for product phase-out.
  • SAP Stage Transition: Shift product lifecycle stages in SAP to Status 50 - Phase Out for decommissioning.
  • Engineering Change Order (ECO) Management: Initiate and manage ECOs to formalize the decommissioning process in manufacturing, ensuring compliance with Medtronic standards and regulatory requirements.
  • PLM Tracker Closure: Complete PLM tracker activities, ensuring accurate and thorough record-keeping and decommissioning documentation.

FAQs

What is the primary role of a Manufacturing Engineer II at Medtronic?

The primary role of a Manufacturing Engineer II at Medtronic involves leading the phase-out process within the Product Lifecycle Management (PLM) framework, ensuring smooth transitions and compliance with regulatory and operational standards in ENT operations.

What are the key responsibilities of this position?

Key responsibilities include designing and optimizing processes for product decommissioning, collaborating with internal teams and suppliers, preparing Engineering Change Orders (ECOs), providing technical support, managing data and status tracking, and ensuring regulatory compliance.

What qualifications are required for this position?

Required qualifications include a Bachelor’s degree in mechanical engineering, Industrial Engineering, or a related field, along with 6-8 years of relevant engineering experience, proficiency in CAD software, strong analytical skills, and knowledge of regulatory compliance.

Is experience with SAP necessary for this role?

Yes, familiarity with SAP and Engineering Change Orders (ECOs) is required for the Manufacturing Engineer II position.

Are there any certifications that would be beneficial for applicants?

Yes, certifications in Six Sigma, Lean Manufacturing, or similar process improvement methodologies are considered beneficial.

What competencies are important for this role?

Important competencies include project management abilities, strong communication and teamwork skills, and a structured problem-solving approach.

What kind of work environment can one expect in this role?

The role requires independent mobility and regular interaction with computerized systems and project teams in a collaborative environment.

Is there an incentive program associated with this position?

Yes, this position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

What is Medtronic’s mission?

Medtronic’s mission is to alleviate pain, restore health, and extend life, uniting a global team dedicated to solving the most challenging health problems.

How does Medtronic support employee development?

Medtronic fosters growth and collaboration, encouraging technical excellence and personal development, ensuring that employees contribute to innovations that enhance healthcare outcomes.

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Medtronic

Engineering the extraordinary

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Medtronic is a global medical technology company that designs, manufactures, and markets a wide range of medical devices and therapies. The company's products and solutions cover a broad spectrum of healthcare areas, including cardiac and vascular therapies, diabetes management, neurological and spinal treatments, surgical technologies, and more. Medtronic's ultimate mission is to improve the lives of patients around the world by advancing medical innovation, providing life-saving and life-enhancing solutions, and transforming the way healthcare is delivered. Their purpose is to alleviate pain, restore health, and extend the lives of patients through cutting-edge medical technologies, personalised therapies, and continuous research and development. With a commitment to delivering quality and affordable healthcare solutions, Medtronic seeks to make a positive impact on patients, healthcare professionals, and healthcare systems worldwide.