Design Assurance Engineer — Medical Devices

Spectraforce Technologies, Inc.; Saint Paul Park (MN); Sur place; USD 67 000 - 89 000; Plein temps

Résumé du poste

Spectraforce Technologies, Inc. seeks a Design Assurance Quality Engineer to support vascular device development in Minnesota.

You will ensure products meet requirements, manage risk, and maintain regulatory compliance with FDA, ISO 13485, and 21 CFR Part 820. The role partners with cross‑functional teams to drive quality from concept through commercialization and sustainment, including design verification/validation and CAPA.

Qualifications

• Bachelor's degree in Engineering or closely related field.
• 2+ years of engineering experience with demonstrated use of quality tools/methodologies.
• Strong verbal, written, and interpersonal communication skills.

Responsabilités

• Lead on-time completion of design assurance deliverables and initiatives.
• Define and verify customer, external, and product requirements.
• Lead risk management from concept to commercialization, including FMEA.
• Support method validation, design verification and design validation planning and execution.
• Support manufacturing process development and qualification for new product commercialization.
• Manage Process Validation planning/execution and CTQ parameter monitoring.
• Review and approve document changes and CAPA records.
• Support DHF content completion and regulatory compliance.
• Collaborate with cross-functional teams to meet customer needs and drive cost/schedule goals.

Connaissances

Quality tools/methodologies

Cross-functional collaboration

Verbal and written communication

Multitasking and prioritization

Travel readiness

Formation

Bachelor's degree in Engineering

Description du poste

Spectraforce Technologies, Inc. seeks a Design Assurance Quality Engineer to support vascular device development in Minnesota.

You will ensure products meet requirements, manage risk, and maintain regulatory compliance with FDA, ISO 13485, and 21 CFR Part 820. The role partners with cross‑functional teams to drive quality from concept through commercialization and sustainment, including design verification/validation and CAPA.