Design Assurance QA Engineer II - Vascular Devices

Lancesoft; Saint Paul (MN); Sur place; USD 85 000 - 120 000; Plein temps

Résumé du poste

Lancesoft in New Brighton, MN (AVSP) seeks a Design Assurance Quality Engineer II to ensure new or modified medical devices meet quality and regulatory requirements. You will lead risk management, verification/validation planning, and CAPA activities across cross-functional teams to protect patient safety and support product development and manufacturing.

The role supports the Vascular division with DRF compliance, process validation, and DHF integrity, collaborating with Program Management and

Qualifications

• Bachelor's degree in Engineering or a closely related discipline.
• 2+ years of engineering experience with quality tools/methodologies.
• Strong verbal, written, and interpersonal communication.
• Ability to operate in a matrixed, geographically diverse environment.
• Ability to travel occasionally (<10%), including internationally.

Responsabilités

• Lead on-time completion of DA design deliverables and initiatives.
• Define objective customer and product requirements.
• Lead Risk Management from concept to commercialization including FMEA support.
• Support Test/Inspection Method development and Method Validation.
• Plan/execute Design Verification and Validation with cross-functional teams.
• Support manufacturing process development and qualification for new products.
• Coordinate Process Validation and monitor CTQ parameters.
• Review and approve change orders and CAPA records in a timely manner.
• Assist product builds in cleanroom for development and commercial activity.
• Maintain DHF content integrity and regulatory compliance.
• Collaborate with cross-functional teams to meet customer needs.

Connaissances

Quality tools/methodologies

Communication

Team collaboration

Multitasking

Formation

Bachelor's degree in Engineering

Outils

21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, MDSAP

Description du poste

Lancesoft in New Brighton, MN (AVSP) seeks a Design Assurance Quality Engineer II to ensure new or modified medical devices meet quality and regulatory requirements. You will lead risk management, verification/validation planning, and CAPA activities across cross-functional teams to protect patient safety and support product development and manufacturing.

The role supports the Vascular division with DRF compliance, process validation, and DHF integrity, collaborating with Program Management and