Manufacturing Engr Ii

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**:
**Manufacturing Engineer II**

**Careers That Change Lives**

Join Medtronic, a global leader in healthcare innovation, and bring your expertise to the forefront of ENT operations. As a Manufacturing Engineer II in the ENT Operations Team, you will play a key role in the Phase out process within our Product Lifecycle Management (PLM) framework. By ensuring smooth transitions and alignment with regulatory and operational standards, 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**:

- 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.
- 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.

One of the key focus areas for this role is in the ENT Operating Unit wherein you will oversee the SKU rationalization of medical device products in the ENT Operations (OPS) team by managing PLM processes. Your responsibilities will focus on:
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.

**Required Qualifications**:

- 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.

**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**:

- 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.

**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**