Prin Manufacturing Engineer

Posted 14hrs ago

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Job Description

Principal Manufacturing Engineer optimizing Medtronic’s medical-device contract manufacturing lines. Driving validation, automation, compliance, and continuous improvement across production operations.

Responsibilities:

  • Provide manufacturing engineering support for management and optimization of 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 service performance
  • 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 to maintain documentation aligned with ISO 13485 and FDA 21 CFR Part 820
  • Drive throughput and reliability improvements 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 root-cause analysis and CAPA for test-related issues
  • Develop and implement processes applicable to statistical process control
  • Contribute to lean manufacturing initiatives and efficiency projects
  • 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, and manufacturing techniques
  • Ensure processes and procedures comply with regulations
  • Formulate, deliver, and manage technical projects; mentor colleagues and guide lower-level professionals
  • Partner with Manufacturing Engineering to integrate test processes into production lines

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, including LBM, OPC, and inventory deferrals
  • Excellent problem-solving skills and comfort working on a fast-paced production floor
  • Experience with statistical analysis tools such as Minitab and JMP and process capability metrics
  • Knowledge of risk management, FMEA, and root-cause analysis methodologies

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
  • Eligibility for the Medtronic Incentive Plan (MIP), a short-term incentive