Prin Manufacturing Engineer
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Job Description
Principal Manufacturing Engineer optimizing fixtures, validation, and processes for Medtronic’s medical-device contract manufacturing network. Driving compliant production-line reliability and continuous improvement.
Responsibilities:
- Provide manufacturing engineering support for manufacturing lines within the Global Contract Manufacturing Platform
- Collaborate with internal businesses, global cross-functional teams, and contract manufacturing partners to identify and mitigate risks
- Drive continuous improvement and maintain consistent service performance from active production lines
- Develop, validate, and maintain production fixtures for medical devices and subassemblies
- Troubleshoot test failures, equipment issues, and process deviations in day-to-day manufacturing operations
- Create and execute IQ/OQ/PQ validation protocols for equipment and manufacturing processes
- Ensure production systems remain compliant, calibrated, and audit-ready
- Collaborate with Quality and Regulatory teams on documentation aligned with ISO 13485 and FDA 21 CFR Part 820
- Improve throughput and reliability through automation, fixture upgrades, and process optimization
- Analyze test data to identify trends, recurring issues, and improvement opportunities
- Design manufacturing processes, procedures, production layouts, machine arrangements, and operation sequences
- Implement statistical process control techniques and lean manufacturing initiatives
- Implement root-cause analysis and CAPA for test-related issues
- Incorporate inspection and test requirements into production plans
- Inspect machinery, equipment, and tool performance and initiate corrective actions
- Provide engineering guidance on design concepts, specifications, equipment utilization, and manufacturing techniques
- Ensure processes and procedures comply with regulations
- Manage major or moderately complex projects, delegate work, review work products, and mentor or guide colleagues
Requirements:
- Bachelor’s degree required
- Minimum of 7 years of relevant medical device manufacturing engineering experience or related field, or an advanced degree with 5 years of relevant experience
- Project planning skills to prioritize tasks and establish frameworks and systems
- Experience working in an FDA regulated industry
- Familiarity with requirements management and IQ, OQ, PQ
- Strong technical engineering background and ability to understand engineering drawings, specifications, and design intent
- Strong understanding of measurement systems, instrumentation, and data acquisition
- Good written and oral communication skills in English
- Strong manufacturing and/or regulatory environment experience in an active medical device or equipment company
- Success leading teams and/or matrix organizations
- Excellent presentation and communication skills
- Strong business acumen and understanding of operations costing (LBM, OPC, inventory deferrals, etc.)
- Excellent problem-solving skills and comfort working on a fast-paced production floor
- Experience with statistical analysis tools such as Minitab or JMP and process capability metrics
- Knowledge of risk management, FMEA, and root-cause analysis methodologies
- Preferred: experience with products ranging from large capital equipment to small consumables
- Preferred: experience working with contract manufacturing finished goods suppliers
Benefits:
- Medtronic offers a competitive Salary and flexible Benefits Package
- Wide range of benefits, resources, and competitive compensation plans designed to support employees at every career and life stage
- Eligible for a short-term incentive called the Medtronic Incentive Plan (MIP)
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