Component Engineer

Responsibilities:

• Lead part qualification activities to support value engineering and quality improvement initiatives.
• Define and establish part qualification requirements including testing and inspection prior to system integration.
• Support supplier transitions and part transfers between vendors.
• Complete Production Part Qualification Process deliverables including supplier pFMEA, special process validations, FAI, and process capability analysis.
• Perform product and process risk analysis and ensure effective mitigation prior to product introduction.
• Establish and sustain process capability at supplier and sub-tier supplier levels.
• Support manufacturing line escalations and drive issue resolution.
• Lead root cause analysis using methodologies such as 8D and 5 Whys and implement corrective and preventive actions.
• Lead manufacturing process selection based on quality, cost, and capacity considerations.
• Identify and implement Design for Manufacturability (DFM) opportunities to improve quality and reduce cost.
• Educate internal teams and suppliers on manufacturing methods, tooling, and supplier capabilities.
• Manage engineering changes through ECO processes and drive improvements to specifications and drawings.
• Lead supplier change management initiatives using Supplier Change Request (SCR) processes.
• Provide readiness status of supply chain in terms of quality, capacity, and delivery for production changes.
• Collaborate cross-functionally to improve supplier engineering and operational processes.
• Support supplier selection by evaluating technical, quality, and business capabilities.
• Participate in supplier audits and support development of supplier quality systems.
• Build and maintain strong supplier relationships to ensure alignment with organizational goals.

Required Skills And Experience:

• Bachelor s degree in Engineering or related field.
• 10+ years of experience in manufacturing, supplier process engineering, design, or related areas.
• Strong knowledge of manufacturing processes and key input variables affecting quality, cost, and capacity.
• Experience with pFMEA, process validation, inspection, and testing techniques.
• Proficiency in root cause analysis tools such as 8D and 5 Whys.
• Ability to evaluate and challenge supplier technical and quality capabilities.
• Strong experience with DFM principles and feedback implementation.
• Ability to read and interpret technical specifications and schematics.
• Familiarity with QMS, GDP practices, and regulatory standards such as 21 CFR Part 820 and ISO 13485.
• Strong computer skills including MS Office and ERP systems, preferably SAP.
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Experience in medical device manufacturing environments.
• Experience auditing suppliers against ISO 13485 and regulatory standards.
• Knowledge of machining (4 & 5-axis), metal fabrication, welding, and bonding processes.
• Experience with plastic injection molding, die casting, or thixomolding.
• Familiarity with mechanical motion products (bearings, gears, screws, motors, brakes).
• Knowledge of motion control sensors such as encoders and inertial sensors.
• Experience in low-volume, high-mix production environments.
• Proven ability to lead teams and influence suppliers to resolve complex technical challenges.