Supplier Manufacturing Engineer

Responsibilities:

• Complete Part Qualification (PPQP) deliverables including supplier pFMEA, process validations (IQ/OQ/PQ), inspection reports, Gage R&R, and process capability analysis.
• Partner with suppliers to drive cost reduction, capacity improvements, and risk mitigation initiatives.
• Select appropriate manufacturing processes and suppliers based on long-term fit and total cost of ownership.
• Manage supplier changes including process updates, production optimization, facility changes, new equipment qualification, and line validations.
• Initiate and manage engineering change orders to update specifications and drawings as required.
• Lead supplier issue resolution from root cause analysis through corrective and preventive actions (CAPA).
• Prioritize and manage multiple concurrent projects and tasks effectively.
• Communicate project status, risks, and updates to key stakeholders.
• Develop and execute supplier development strategies to enhance performance and reliability.
• Generate and track key performance metrics for suppliers and drive continuous improvement.
• Drive supplier excellence using Lean, Six Sigma, SPC, and project management best practices.
• Support New Product Introduction (NPI) by assessing supplier readiness, capacity, and quality performance.
• Engage suppliers early in design phases to provide Design for Manufacturability (DFM) feedback.
• Influence supplier selection by defining criteria and leading evaluation processes.
• Review and resolve customer complaints, manufacturing variances, and first-article inspection issues.
• Evaluate and implement corrective actions to prevent recurrence of supplier-related issues.

Required Skills And Experience:

• Strong experience in supplier manufacturing engineering, quality engineering, and production processes.
• Proficiency in pFMEA, process validation (IQ/OQ/PQ), root cause analysis, and inspection techniques.
• Experience with manufacturing processes such as machining, plastic injection molding, metal injection molding, and contract manufacturing.
• Strong knowledge of Lean, Six Sigma, and statistical process control (SPC).
• Experience in New Product Introduction (NPI) and scaling production in high-volume environments.
• Familiarity with ERP and document management systems such as SAP and Agile.
• Knowledge of regulatory standards such as 21 CFR Part 820 and ISO 13485 (preferred).
• Strong analytical, problem-solving, and project management skills.
• Excellent communication and stakeholder management skills, including executive-level presentations.

Education:

• Bachelor s degree in Engineering required.
• Master s degree in Engineering preferred.

Years of Experience:

• 6+ years with a Bachelor s degree OR 4+ years with a Master s degree.