Quality-Centric Product Design Engineer (Medical Devices)

Creative Solutions Services, LLC; Bothell (WA); On-site; USD 120,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC in Bothell, WA, is seeking a Product Design Quality Engineer to ensure regulatory compliance, design controls, and quality throughout the product development lifecycle.

You will collaborate with R&D, Regulatory Affairs, Manufacturing, and QA to lead design V&V, risk analyses (FMEA), change control, and manufacturing transfer readiness. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and CAPA processes is required.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Healthcare Management, or related field.
• 5+ years in Design Quality/Design Assurance/Quality Engineering in FDA-regulated medical devices.
• Strong knowledge of Design Controls, V&V, and lifecycle management.
• Experience with design traceability, ECR/ECO, and manufacturing transfer.

Responsibilities

• Support Design Control activities in accordance with FDA and international regulations.
• Participate in design planning, reviews, and V&V to meet quality objectives.
• Review and approve design documentation and traceability records.
• Maintain DHF, DMR, and related quality documentation.
• Collaborate with R&D, Regulatory Affairs, Manufacturing, and supplier quality.
• Facilitate FMEA, hazard analyses, and risk control implementations.
• Support design transfer activities to ensure readiness for production.
• Contribute to internal audits, CAPA investigations, and QMS improvements.
• Contribute to QMS enhancements and regulatory compliance efforts.

Skills

Quality engineering

FDA regulations

Design controls

V&V

Risk management

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Creative Solutions Services, LLC in Bothell, WA, is seeking a Product Design Quality Engineer to ensure regulatory compliance, design controls, and quality throughout the product development lifecycle.

You will collaborate with R&D, Regulatory Affairs, Manufacturing, and QA to lead design V&V, risk analyses (FMEA), change control, and manufacturing transfer readiness. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and CAPA processes is required.