Component Engineer

Roles and Responsibilities:

• Drive projects with suppliers to continuously improve business and manufacturing process performance, aligning with standards for supplier excellence.
• Identify and select processes and suppliers that align with long-term fit and total cost of ownership considerations.
• Lead project and part qualification activities including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis.
• Collaborate with suppliers to achieve cost reductions, increase capacity, and mitigate risks effectively.
• Manage supplier-related changes such as process optimizations, facility changes, and new equipment qualifications.
• Conduct root cause analyses and implement corrective actions for supplier variances, ensuring comprehensive CAPA/SCAR documentation.
• Establish and track key metrics to drive performance improvements and ensure timely achievement of goals.

Skill/Job Requirements:

• A Bachelor's degree in Engineering or equivalent experience; an advanced degree is preferred.
• Minimum of 10 years of experience in engineering and manufacturing, with at least 3 years in Supplier Management and Development roles.
• Proven leadership skills in solving complex technical and process problems.
• Previous experience in Medical Device manufacturing is highly desirable.
• Expertise in manufacturing processes such as machining, metal injection molding, stamping, and welding; knowledge of plastic injection molding is a plus.
• Deep understanding of materials and their implications on design and manufacturability.
• Proficiency in interpreting mechanical drawings and technical communication.
• Strong computer skills, including proficiency in Windows, Word, Excel, Access, and ERP systems (preferably SAP and Agile).