Supplier Process Engineer
Supplier Process Engineer
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Job Description
Primary Function of Position
The mission of Supplier Engineering is to develop a world-class supplier network for our products that ensures continuity of supply scales to meet demand reduces costs and anticipates and mitigates supply chain risks. Supplier Engineers collaborate throughout the product development lifecycle executing strategic projects to optimize commodities sub-commodities and individual suppliers. They carry out detailed initiatives with suppliers to implement changes and improvements that impact quality cost capacity risk and sub-supplier management as well as to launch new products.
This role specifically focuses on the manufacturing of catheters vision probes and needles for medical applications. The ideal candidate should have experience in bringing medical devices to market preferably in the medical device sector or similar regulated industries.
Essential Job Duties
- Work with suppliers to execute cost reductions capacity improvements and risk mitigation.
- Select the right process and supplier for the part considering long term fit and total cost of ownership.
- Work with product development test engineering and supplier to design develop qualify and implement functional test processes at supplier.
- Manage supplier changes including manufacturing process changes production optimization facility changes new equipment qualification and new line validations
- Collaborate with suppliers and internal stakeholders to determine deliverables and define timelines.
- Complete project deliverables including: Supplier pFMEA Component Qualification (FAIR) Process Validations (IQ/OQ/PQ) Inspection Reports Gage R&R and Process Capability Analysis.
- Lead the team in overcoming difficult process issues.
- Develop suppliers to excel in all KPIs including Supplier owned quality capacity and sub-tier management.
- Drive changes to ISI requirements as necessary by initiating and managing changes to specifications and drawings through the engineering change order process.
- Own and drive to closure supplier variances from symptom through root cause analysis to corrective action including careful CAPA/SCAR documentation.
- Provide technical support for failure analysis of discrepant production components assemblies and field returns. Lead investigations where appropriate.
- Effectively prioritize and advance multiple concurrent projects and tasks.
- Clearly communicate project status to key stakeholders internally and in our supply chain.
Qualifications :
Required Skills and Experience
- Experience in engineering and manufacturing of medical devices and the aviation industry.
- 5 years of experience in Supplier Development Supplier Engineering Supplier Process or related field preferred.
- Excellent written and verbal communication skills in English (Full Bilingual) a natural team builder/leader.
- Excellent analytical and problem-solving skills along with good judgment.
- Demonstrable knowledge in evaluating and challenging supplier technical quality and business capabilities.
- Experience in a high-volume medical device company is a plus.
- Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information.
- Ability to travel to suppliers on an as-needed basis domestic and international.
Required Education and Training
- BS degree in Electrical Engineering Mechanical Engineering or equivalent.
- Knowledge of Six Sigma and Lean Manufacturing techniques certification preferred.
- Knowledge of 21 CFR part 820 and ISO 13485 is a plus.
- Proficient in MS Office and ERP Information Systems preferably SAP.
- Available for international travel (20% of the year) and have a valid visa
Working Conditions
- Ability to travel to suppliers on an as-needed basis domestic and international.
Preferred Skills and Experience
- Experience in a high-volume medical device company is a plus.
- Knowledge of 21 CFR part 820 and ISO 13485 is a plus.
Additional Information :
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados y prohibimos cualquier tipo de discriminacin y acoso independientemente de su raza sexo condicin de embarazo orientacin sexual identidad de gnero origen nacional color edad religin condicin de veterano protegido o de discapacidad informacin gentica o cualquier otra condicin protegida por las leyes federales estatales o locales aplicables.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
