The Associate Director, 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, design failure mode effect analysis, and development of risk management plans and reports. This role may have direct reports supporting medical device product development efforts. This individual has a depth of knowledge and experience in medical device new product development along with strong management skills.

Responsibilities:

• Provides quality system methodology guidance, support, and review for medical device products throughout the design and development and change control processes.
• Actively participates and/or supports their team members who participate 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, usability, 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.
• Implements Design Control, Risk Management and Usability process improvements to ensure a more effective, efficient, and compliant processes.
• Maintain compliance with global Risk Management processes in accordance with ISO 14791 and other applicable standards. Work cross-functionally with the Subject Matter Experts from R&D, Clinical, and Operations to ensure the risk process is applied comprehensively.
• Facilitates and leads design and reliability activities related to Design, Manufacturability, and Reliability (DRM) practices. This includes planning, leading, facilitating, and supporting activities such as robust engineering, reliability predictions, capability analysis, development of CTQ's, VOC, requirements flow down, etc.
• Ensures that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
• Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals and Medical Devices worldwide.
• Interprets regulations and trends and recommends/executes changes to quality standards to ensure conformance and continuous improvement.

Qualifications:

• 10+ years’ experience working in the Medical Device industry; 5+ years’ experience working in project and/or people management
• Minimum of a BS in Engineering or Scientific discipline; MS preferred
• Thorough knowledge of Medical Device development activities
• Proven expertise with interpreting, applying, and leading others in compliance with 21 CFR Part 820 Quality System Regulation, ISO 13485
• Standard, ISO 14971 Risk Management Standard, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices
• Skilled in requirements analysis, including testable and measurable specifications
• Strong experience with reliability analysis and test methods and test method validation
• Excellent verbal (including presentation) and written communication skills, especially technical report writing
• Ability to effectively influence others and work within the Allergan organization as well as partnering with external partners
• Ability to operate independently, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines.
• Experience interacting with regulatory agencies and notified bodies.
• In depth knowledge and experience with corrective action and preventive action system, statistical process control, quality risk management, FMEA, DOE and other key tools for managing quality performance.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.