Design Assurance Quality Engineer - Vascular Devices

Spectraforce Technologies, Inc.; Saint Paul (MN); Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

Spectraforce Technologies, Inc. is seeking a Design Assurance Quality Engineer for the Saint Paul, MN area.

You will ensure new or modified medical devices meet regulatory and company quality requirements, support product development, and maintain DHF content with a focus on patient safety and regulatory compliance. You will lead design verification and validation activities, CAPA, risk management, and documentation control, collaborating with cross-functional teams to enable on-time product

Qualifications

• Bachelor's degree in engineering or closely related discipline is required.
• 2+ years engineering experience with quality tools/methodologies.
• Solid verbal and written communication, able to interact across levels.
• Able to work in a highly matrixed, geographically diverse environment.
• Ability to multi-task, meet deadlines, and work independently or in a team.
• Willingness to travel occasionally (<10%), including international trips.

Responsabilités

• Lead on-time completion of design assurance deliverables and initiatives.
• Define objective customer and product requirements and verification criteria.
• Lead risk management from concept to commercialization, including FMEA.
• Support test/inspection method development and validation activities.
• Plan and execute design verification/validation with root-cause analysis.
• Support manufacturing process development for product changes and commercialization.
• Oversee process validation planning/execution and monitor CTQ metrics.
• Review and approve change orders and CAPA records promptly.
• Assist product builds in cleanroom for development and commercial use.
• Maintain DHF integrity and regulatory compliance; close gaps promptly.
• Collaborate with cross-functional teams and external suppliers to meet needs.

Connaissances

Engineering background

Quality tools

Strong communication

Team collaboration

Travel ability

Formation

Bachelor's degree in Engineering or related discipline

Description du poste

Spectraforce Technologies, Inc. is seeking a Design Assurance Quality Engineer for the Saint Paul, MN area.

You will ensure new or modified medical devices meet regulatory and company quality requirements, support product development, and maintain DHF content with a focus on patient safety and regulatory compliance. You will lead design verification and validation activities, CAPA, risk management, and documentation control, collaborating with cross-functional teams to enable on-time product