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
Never miss an opportunity! Create an alert based on the job you applied for.