Are you interested in joining a dynamic, exciting opportunity within a development team for complex medical devices?
A Senior Design Quality Engineer is required. The Design Quality Engineer is a technical authority in the development and deployment of the convergent technologies needed to bring new and innovative products to market. The incumbent is responsible for design control compliance, and product risk management. The role conducts all activities in compliance with regulatory and company procedures. The position will report to the Senior Manager, Quality.
Responsibilities
Activities of the incumbent include but are not limited to:
- Support new product design and development, design transfer, design validation, design review, risk management, etc. working closely with Device Engineering through the entire product life cycle.
- Design control compliance ensuring consistent, workable and compliant planning, development (inputs, outputs and review), testing (verification, validation and review), and change management;
- Regulatory compliance: ensuring product development (including software) and maintenance in accordance with FDA QSR's (21 CFR Part 820), ISO 13485, EU MDR, CMDR, MDD, J-PAL, IEC 62304 and relevant guidance documents (FDA, etc)
- Design risk management, assuring appropriate and consistent risk management tool use i.e. FMEA, FTA, etc. for all programs and projects, compliant with regulatory standards (ISO/EN 14971) and industry practices,
- Supervision of and contribution to pre- and post- market risk assessments;
- Interact with other functions such as Global Design Engineering (GDE), Manufacturing, Regulatory, Product Monitoring, Clinical and Operations as necessary
- Perform internal and supplier audits
- This role may be required to lead personnel (inside and outside) within the Quality organization in support of the business need
- Supplier qualification, vendor management and performance evaluation
- Other tasks deemed necessary by the Senior Manager, Quality.
Education, Experience and Competencies
- Bachelor degree in science, microbiology, engineering or equivalent technical field with 8+ years of applicable industry experience is required or a MS with 4+ years of applicable industry experience is required.
- Experience in medical device design control including software development and product realization
- Competence in statistical tools including design of experiments and sampling methods
- Experience in design quality assurance, risk management
- Problem solving skills e.g root cause analysis and CAPA implementation
- Understanding of one or more subsystem technologies: electrical, mechanical pneumatic and / or software systems
- Understanding of human factors and user-interface design
- Knowledge of medical device regulations including FDA, GMP, design controls, ISO 13485, EU MDR, IEC 62304, ISO 14971, etc.
- Lead auditor certification
- Experience in supplier management
- Excellent written, verbal and interpersonal communications skills are required.
- Experience working with a cross-functional team
- Leadership skills.
