Principal Manufacturing Engineer
About The Position
At Medtronic Neuroscience, we are redefining what's possible in neurological and spinal care, bringing together innovation, expertise, and partnership to improve lives around the world. At Medtronic ENT, we deliver innovative technologies that help clinicians treat complex ear, nose, and throat conditions with greater precision and confidence. Our solutions enhance patient outcomes across both office and surgical settings. This person will be responsible for driving operational excellence by ensuring the successful design, development, deployment, operation, and optimization of the Manufacturing Execution System (MES). Conduct various studies pertaining to cost reduction, Return on Investment (ROI), inventory control and production record systems. Define Manufacturing Execution System (MES) architecture, configuration, and implementation of MES workflows to support production operations and regulatory traceability. Define Standard Operating Procedure (SOP) and data models linking MES with ERP (Enterprise Resource Planning) and other Manufacturing and quality systems within the manufacturing environment. Comply with Medical industry standards system testing and validation according to Good Manufacturing Practices (GMP), 21 CFR Part 11 requirements, regulations and quality mgmt. requirements by conducting audits and implementing controls to ensure regulatory compliance. Monitor performance of the MES system to ensure efficiency by analyzing system metrics, identifying areas for optimization and implementing system enhancements. Apply DMAIC (Design, Measure, Analyze, Improve, and Control) problem solving methodologies. Develop and maintain digital manufacturing documentation, including work instructions and process maps, within the MES framework. Conduct Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) system validation protocols involving test steps per production line to ensure MES compliance with regulations.
Requirements
- Bachelor's degree in Engineering, Manufacturing Engineering, Industrial Engineering, Computer Science, Information Systems, or related technical field.
- 7+ years of experience in manufacturing engineering, manufacturing systems, digital manufacturing, MES, or related technical disciplines.
- Experience implementing, supporting, or optimizing Manufacturing Execution Systems (MES) in a regulated manufacturing environment.
- Experience working with ERP, quality, and manufacturing systems integrations.
- Knowledge of manufacturing process controls, quality systems, and regulatory requirements, including GMP and 21 CFR Part 11.
- Experience supporting software validation and qualification activities within regulated industries.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Nice To Haves
- Advanced degree in Engineering, Manufacturing, Operations, or related field.
- Medical device, pharmaceutical, biotech, or other highly regulated industry experience.
- Experience with MES platforms such as Tulip, Camstar, Opcenter, FactoryTalk, PAS-X, or similar solutions.
- Experience with electronic batch records (EBR) or electronic device history records (eDHR).
- Lean Manufacturing, Six Sigma Green Belt/Black Belt, or equivalent continuous improvement certification.
- Experience supporting digital transformation, Industry 4.0, smart factory, or connected manufacturing initiatives.
- Experience developing manufacturing dashboards, KPIs, and data analytics solutions.
- Project Management certification (PMP) or equivalent project leadership experience.
- Experience supporting internal, customer, or regulatory audits.
Responsibilities
- Lead the implementation, enhancement, and ongoing support of Manufacturing Execution Systems (MES) to improve manufacturing performance, quality, compliance, and operational efficiency.
- Partner with Operations, Manufacturing, Quality, Engineering, and IT teams to design, optimize, and deploy digital manufacturing solutions.
- Develop and maintain manufacturing workflows, system configurations, work instructions, and technical documentation to support business processes.
- Drive continuous improvement initiatives through analysis of manufacturing processes, system performance, and operational data.
- Ensure manufacturing systems comply with applicable regulatory requirements and internal quality standards.
- Support system validation activities, including protocol development, testing, documentation, and change control processes.
- Manage complex cross-functional projects related to manufacturing systems, automation, and process improvements.
- Provide technical leadership and subject matter expertise for MES architecture, system integration, and manufacturing technologies.
- Train and mentor users on manufacturing systems, processes, and best practices.
- Collaborate with stakeholders to identify business needs and translate requirements into scalable manufacturing solutions.
Benefits
- Competitive Salary and flexible Benefits Package
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
