Prin Manufacturing Engineer

This is a fully remote position, open to applicants in China.

📋 Description

• Provide engineering support for manufacturing processes within the Global Contract Manufacturing Platform.

• Collaborate with internal stakeholders, global cross-functional teams, and contract manufacturing partners to identify and address risks.

• Drive continuous improvement initiatives and ensure consistent service performance on active production lines.

• Develop, validate, and maintain production fixtures for medical devices and their subassemblies.

• Diagnose test failures, equipment malfunctions, and process deviations in daily manufacturing operations.

• Create and implement IQ/OQ/PQ validation protocols for both equipment and manufacturing processes.

• Ensure that production systems remain compliant, calibrated, and ready for audits.

• Work alongside Quality and Regulatory teams to ensure documentation aligns with ISO 13485 and FDA 21 CFR Part 820.

• Enhance throughput and reliability through automation, fixture improvements, and process optimization.

• Analyze test data to identify trends, recurring issues, and opportunities for improvement.

• Design manufacturing processes, procedures, production layouts, machine configurations, and operation sequences.

• Implement statistical process control techniques and lean manufacturing practices.

• Conduct root-cause analysis and CAPA for testing-related issues.

• Integrate inspection and testing requirements into production plans.

• Evaluate machinery, equipment, and tool performance while initiating corrective actions as needed.

• Provide engineering advice on design concepts, specifications, equipment usage, and manufacturing methods.

• Ensure that processes and procedures adhere to relevant regulations.

• Manage major or moderately complex projects, delegate tasks, review deliverables, and mentor or guide team members.

⛳️ Requirements

• A bachelor's degree is required.

• At least 7 years of relevant experience in medical device manufacturing engineering or a related field, or an advanced degree with 5 years of relevant experience.

• Project planning abilities to prioritize tasks and establish frameworks and systems.

• Experience in an FDA-regulated industry.

• Familiarity with requirements management and IQ, OQ, PQ processes.

• Strong technical engineering expertise with the ability to interpret engineering drawings, specifications, and design intent.

• Solid understanding of measurement systems, instrumentation, and data acquisition methods.

• Proficient written and verbal communication skills in English.

• Significant experience in a manufacturing or regulatory environment within an active medical device or equipment company.

• Proven success in leading teams and/or matrix organizations.

• Excellent presentation and communication capabilities.

• Strong business acumen with a good grasp of operations costing (LBM, OPC, inventory deferrals, etc.).

• Exceptional problem-solving skills and adaptability to a fast-paced production environment.

• 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 collaborating with contract manufacturing finished goods suppliers.

🏝️ Benefits

• Medtronic provides a competitive salary along with a flexible benefits package.

• A comprehensive range of benefits, resources, and competitive compensation plans designed to support employees at every stage of their career and life.

• Eligible for a short-term incentive known as the Medtronic Incentive Plan (MIP).