Senior Design Quality Engineer

United Pharma; Utah; In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

United Pharma in Utah is seeking a Senior Design Quality Engineer to lead design controls, product risk management, and post-market surveillance across NV devices.

You will develop qualification plans, run tests, conduct root-cause analyses, maintain risk files, and collaborate with engineering, regulatory, manufacturing, and quality teams to drive quality improvements throughout the product lifecycle.

Competenze

• Bachelor’s degree in Engineering or related technical discipline.
• Minimum 2 years of engineering or quality/related role.
• Experience with structured problem-solving methodologies and quality improvement tools.
• Experience supporting product testing, validation, verification, and risk management.

Mansioni

• Develop qualification plans, protocols, and reports for new and existing products.
• Execute product testing, inspection, verification, and validation activities.
• Perform failure investigations and root cause analyses.
• Create, maintain, and update product risk management documentation.
• Conduct risk assessments and support design reviews.
• Apply statistical methods and problem-solving tools to support investigations.
• Collaborate with engineering, regulatory, manufacturing, and quality teams.

Conoscenze

Structured problem solving

Quality improvement tools

Statistical analysis

Cross-functional collaboration

Formazione

Bachelor's degree in Engineering or related technical discipline

Descrizione del lavoro

As the Senior Design Quality Engineer, you will be actively involved in Product Risk Management, Post Market Surveillance, Design Control and Product Quality Improvement. You will be involved in a fast-paced mix of short design change efforts and will be responsible for product risk management and adherence to design control requirements throughout the product lifecycle. You will be responsible for ensuring that post market data and feedback is channeled into the risk management system throughout the product lifecycle. You will make regular use of problem-solving tools and statistical analysis to analyze and trend data and provide quality input into technical investigations, perform test method development and validation, design verification, risk assessment and design reviews. You will be responsible for supporting product testing and failure analysis, writing protocols and reports, creating and maintaining risk files and assessing the impact of necessary changes to our products. You will lead initiatives to increase sales and improve the customer experience of our devices.

Neurovascular (NV) products push the boundaries of technology to meet ever increasing product performance requirements, making the goal of assessing and demonstrating, safety, performance and compliance an exciting challenge.

What You Will Do

• Develop qualification plans, protocols, and reports for new products, existing products, components, and subassemblies.
• Execute product testing, inspection, verification, and validation activities to support design and quality objectives.
• Perform failure investigations and root cause analyses to identify product and process improvement opportunities.
• Create, maintain, and update product risk management documentation throughout the product lifecycle.
• Conduct risk assessments and support design reviews in accordance with applicable quality system and design control requirements.
• Apply statistical methods and problem-solving tools to support test method development, validation activities, and engineering investigations.
• Analyze specifications, test results, and process data, and recommend revisions to improve product quality and performance.
• Collaborate with engineering, regulatory, manufacturing, and quality teams to support product development, design changes, and compliance activities.

Required

What You Need

• Bachelor’s degree in Engineering or a related technical discipline.
• Minimum 2 years of experience in engineering, quality engineering, manufacturing engineering, or a related technical role.
• Experience using structured problem-solving methodologies and quality improvement tools.
• Experience supporting product testing, validation, verification, risk management, or process improvement activities.