About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 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. Responsibilities Include: 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. 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 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 Quality Standard, ICH Q9 Guidance for Industry – Quality Risk Management, 21 CFR 4 Regulation of Combination Products, SOR 98-282 Canadian Medical Device Regulation, ISO 14971 Risk Management Standard, MDD, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices Skilled in requirements analysis, including testable and measurable specifications Familiar with reliability analysis and test methods and test method validation 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 Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.