Senior Design Quality Engineer Medical Devices | Design Controls & Risk Management | Contract | Onsite - Bothell, WA / Cambridge, MA| $55/hr on C2C

Senior Design Quality Engineer Medical Devices | Design Controls & Risk Management

Onsite Location: Bothell, WA / Cambridge, MA
Job Type: Contract

Job Overview

We are seeking an experienced Senior Design Quality Engineer / Design Assurance Engineer with strong experience in FDA-regulated medical device environments.

The ideal candidate will have hands-on experience with Design Controls, Design Verification & Validation, Risk Management, CAPA, Change Control, Design Transfer, and Quality Management Systems.

The candidate will work closely with R&D, Regulatory, Manufacturing, Quality, Engineering, and external stakeholders to ensure product designs meet applicable regulatory, quality, safety, reliability, and customer requirements.

Key Responsibilities

• Support and ensure compliance with medical device Design Control requirements throughout the product lifecycle.
• Participate in design planning, design reviews, design verification, and design validation activities.
• Review design inputs, design outputs, specifications, and technical documentation.
• Develop and maintain design traceability matrices and supporting design documentation.
• Support and review DHF, DMR, and DHR documentation.
• Ensure Design Verification & Validation activities meet defined requirements and quality standards.
• Review and support ECR/ECO and engineering change control activities.
• Ensure design changes follow appropriate quality and regulatory processes.
• Support design transfer activities and manufacturing readiness.
• Partner with R&D, Regulatory, Manufacturing, Engineering, and Quality teams throughout product development.
• Evaluate critical design inputs related to usability, reliability, performance, manufacturability, and safety.
• Support product and process risk management activities.
• Facilitate or support FMEA, hazard analysis, and risk assessment activities.
• Ensure risk controls are implemented, verified, and documented.
• Support quality audits and regulatory inspections.
• Manage and support CAPA, root cause analysis, corrective actions, and preventive actions.
• Contribute to development and continuous improvement of QMS processes.
• Provide quality guidance and technical support to cross-functional project teams.

Required Qualifications

• Bachelor's degree in Biomedical Engineering, Medical Sciences, Healthcare Management, Engineering, or a related field.
• 5+ years of experience in FDA-regulated medical device environments.
• Strong experience with Design Assurance / Design Controls.
• Strong knowledge of 21 CFR Part 820 and ISO 13485.
• Strong understanding of ISO 14971 and medical device risk management.
• Hands-on experience with Design Verification & Validation (V&V).
• Experience with design traceability, DHF, DMR, and DHR.
• Experience with ECO/ECR and design change control.
• Experience with CAPA and root cause analysis.
• Experience supporting design transfer/manufacturing transfer.
• Strong understanding of medical-device quality and regulatory requirements.

Preferred Qualifications

• Experience with EU MDR and MDD 93/42/EEC.
• Knowledge of Canadian Medical Devices Regulations.
• Experience with FMEA / DFMEA / PFMEA.
• Design for Reliability / Design for Quality experience.
• Experience supporting regulatory audits and inspections.
• Experience working in cross-functional medical-device product development teams.
• Strong documentation, communication, and stakeholder-management skills.

Keywords

Design Quality | Design Assurance | Design Controls | Medical Devices | FDA | 21 CFR 820 | ISO 13485 | ISO 14971 | Risk Management | FMEA | V&V | Design Verification | Design Validation | DHF | DMR | DHR | Traceability | CAPA | ECO | ECR | Design Transfer | Medical Device Quality