The Senior Manager, R&D Device Quality will support the development of medical devices and/or device components of combination products by providing direction on applicable design control, human factors/usability engineering, and risk management processes. This position will engage with all areas involved in the product development process and provide direction and consultation assuring the design control system is effectively established, executed, and maintained. This position will participate in product risk assessment efforts, including hazard analysis and design failure mode effect analysis, and development of the risk management plans.
• Provides quality system methodology guidance, support and review for medical device products throughout the design and development and change control processes.
• Actively participates on cross-functional design teams assessing design documentation for quality characteristics, including: product requirements, safety risk management, design verification, design validation, manufacturability, serviceability, biocompatibility, sterilization, packaging and reliability.
• Works with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability.
• Serves as a technical resource for problem investigations to guide root cause analysis / corrective action development.
• Provides clear and regular technical and administrative direction to personnel assigned to a project. Requires broad perspective of company, regulatory and site policies and procedures, in addition to personal representation and leadership abilities...cont.