Prin Manufacturing Engineer

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

📋 Description

• Provide engineering support for manufacturing to enhance and optimize production lines within the Global Contract Manufacturing Platform.

• Work in collaboration with internal businesses, global cross-functional teams, and contract manufacturing partners to identify risks, drive continuous improvement, and uphold service performance.

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

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

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

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

• Collaborate with Quality and Regulatory teams to keep documentation in line with ISO 13485 and FDA 21 CFR Part 820 standards.

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

• Analyze test data to detect trends, recurring problems, and opportunities for improvement.

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

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

• Develop and apply processes relevant to statistical process control.

• Contribute to lean manufacturing initiatives and efficiency improvement projects.

• Integrate inspection and testing requirements into production plans.

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

• Provide engineering insights on design concepts, specifications, equipment, and manufacturing techniques.

• Ensure all processes and procedures adhere to regulatory standards.

• Formulate, deliver, and oversee technical projects; mentor colleagues and guide junior professionals.

• Collaborate with Manufacturing Engineering to assimilate test processes into production lines.

⛳️ Requirements

• Bachelor’s degree is required.

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

• Skills in project planning to prioritize tasks and set up frameworks and systems.

• Experience in an FDA-regulated industry.

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

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

• Thorough understanding of measurement systems, instrumentation, and data acquisition.

• Good written and verbal communication skills in English.

• Significant experience in manufacturing and/or regulatory environments within an active medical device or equipment company.

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

• Excellent presentation and communication abilities.

• Strong business acumen with a grasp of operations costing, including LBM, OPC, and inventory deferrals.

• Exceptional problem-solving skills and the ability to thrive in a fast-paced production environment.

• Experience with statistical analysis tools such as Minitab and JMP, and familiarity with process capability metrics.

• Knowledge of risk management, FMEA, and root-cause analysis methodologies.

🏝️ Benefits

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

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

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