Design Assurance Engineer: Shape Safer Medical Devices

Saluda Medical; Minnetonka (MN); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Saluda Medical, headquartered in Minneapolis, Minnesota, seeks a Design Assurance Engineer to drive design controls and quality across the product lifecycle from concept to commercialization.

The role supports product development, sustaining engineering, and post-market activities, ensuring DHF and design controls align with regulatory expectations and cross-functional collaboration is strong.

Qualifications

• Bachelor's degree or higher in a technical field (Biomedical, Mechanical, Electrical Engineering or other technical field).
• Experience mentoring cross-functional teams in design controls and risk management.
• Knowledge of FDA regulations or ISO standards (preferred).

Responsabilités

• Identify and implement design controls to support product development from concept through commercialization.
• Ensure activities comply with internal and regulatory requirements through cross-functional collaboration.
• Mentor cross-functional teams on design control and risk management deliverables.
• Conduct risk analyses using FMEA and other risk management tools.
• Stay current on regulatory requirements for design, development, transfer, and commercialization.
• Support quality decisions and practices across departments.
• Collaborate with internal and external partners.
• Review design verification test plans, protocols and reports.
• Develop test method validation requirements.

Connaissances

Cross-functional teamwork

Independent work

Strong analytical skills

Effective communication

Prioritization under ambiguity

Regulatory awareness (FDA/ISO)

Formation

Bachelor's or higher in a technical field

Description du poste

Saluda Medical, headquartered in Minneapolis, Minnesota, seeks a Design Assurance Engineer to drive design controls and quality across the product lifecycle from concept to commercialization.

The role supports product development, sustaining engineering, and post-market activities, ensuring DHF and design controls align with regulatory expectations and cross-functional collaboration is strong.