[Hiring] Principal Manufacturing Engineer @Medtronic

Role Description

Provide manufacturing engineering support to enable the successful management and optimization of manufacturing lines within the Global Contract Manufacturing Platform. Work collaboratively with our internal businesses, global cross functions, 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.
• Support day‑to‑day manufacturing operations by troubleshooting test failures, equipment issues, and process deviations.
• Create and execute validation protocols (IQ/OQ/PQ) for equipment and manufacturing processes.
• Ensure all 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 requirements.
• Drive improvements in throughput and reliability through automation, fixture upgrades, and process optimization.
• Analyze test data to identify trends, recurring issues, and opportunities for improvement.
• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Implement root‑cause analysis and corrective/preventive actions (CAPA) for test‑related issues.
• Develop and implement manufacturing processes that are applicable to statistical process control and may develop those techniques.
• Contribute to lean manufacturing initiatives and efficiency projects.
• Design arrangement of machines within manufacturing facilities to ensure the most efficient and productive layout.
• Design sequence of operations and specify procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapt machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigate and initiate corrective action of problems and deficiencies to ensure product quality.
• Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensure processes and procedures are in compliance with regulations.

Qualifications

• Bachelor’s degree required.
• Minimum of 7 years of relevant medical device manufacturing engineering experience or related field, or advanced degree with 5 years of relevant medical device manufacturing engineering experience or related field.
• Must have project planning skills to prioritize tasks and establish framework and systems for managing areas of responsibility.
• Experience working in an FDA regulated industry, familiarity with requirements management and IQ, OQ, PQ.
• Strong technical engineering background, able to understand engineering drawings, specs, and true design intent.
• Strong understanding of measurement systems, instrumentation, and data acquisition.
• Must have good written and oral communication skills (English).
• Strong manufacturing and/or regulatory environment experience in Active Medical device or equipment company.
• Demonstrate 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 (e.g., Minitab, JMP) and process capability metrics.
• Knowledge of risk management, FMEA, and root‑cause analysis methodologies.

Requirements

• Experience working on a range of scales and complexity of product from large capital equipment to small, less complex consumables.
• Experience working with contract manufacturing finished goods suppliers.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package.
• A commitment to our employees lives at the core of our values.
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).