Component Engineer

Responsibilities:

• Complete Part Qualification (PPQP) deliverables including supplier pFMEA, process validations (IQ/OQ/PQ), inspection reports, Gage R&R, and process capability analysis.
• Collaborate with suppliers to drive cost reduction, capacity improvements, and risk mitigation initiatives.
• Select optimal manufacturing processes and suppliers based on long-term fit and total cost of ownership.
• Manage supplier changes including process updates, facility changes, new equipment qualification, and production line validations.
• Initiate and manage engineering change orders to update specifications, drawings, and ISI requirements.
• Drive supplier issue resolution from root cause analysis through corrective and preventive actions (CAPA).
• Prioritize and manage multiple concurrent projects while ensuring timely delivery of outcomes.
• Communicate project status, risks, and progress to key stakeholders and leadership.
• Develop and execute supplier development strategies to improve performance and reliability.
• Track key performance metrics for suppliers and drive continuous improvement.
• Lead supplier performance improvements using Lean, Six Sigma, SPC, and project management best practices.
• Support New Product Introduction (NPI) by evaluating supplier readiness, capacity, and quality performance.
• Engage suppliers early in design phases to provide Design for Manufacturability (DFM) feedback.
• Influence supplier selection by defining evaluation criteria and leading assessment 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 quality engineering, manufacturing processes, and component engineering.
• 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).
• Excellent analytical, problem-solving, and project management skills.
• Strong 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:

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