About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com. The Senior Systems Engineer will be responsible for translating user and business needs into system and subsystem requirements, system-level design, architecture definition, and integration of complex electro-mechanical systems with software. The engineer is experienced in all aspects of product development life cycle with strong understanding of systems engineering processes and human factors/usability engineering in a regulated industry. The Systems Engineer will work with a multi-disciplinary engineering team including software, electrical, and mechanical engineers, and other functions to ensure high quality product introductions for class II medical devices. We are looking for a motivated self-starter who is energetic, has a ‘make it happen’ attitude and can thrive in a fast-paced environment. Main Areas of Responsibilities: Within the Product Development team lead the systems engineering and usability engineering activities for complex electro-mechanical medical devices. Translate customer needs, research findings and business requirements into product requirements and specifications. Develop and maintain product specifications, requirements documents, product use cases, usability engineering file, and other technical documentation. Lead risk analysis activities for the product development including Use FMEA, Design FMEA, hazards analysis, and identifying critical tasks. Define usability evaluation plans, conduct and coordinate usability testing activities, ensure that design, testing, documentation and regulatory submittal activities are fully compliant with and reflect best-practices of all relevant Human Factor (HF) & usability-related standards and guidance documents. Identify HF / usability related organizational needs; work with senior management to establish internal capabilities and external relationships needed to support on-going business needs. Ensure system design and appropriate supporting documentation meets all safety and regulatory and industry compliance standards and codes. Communicate and collaborate with a wide range of project contributors and stakeholders spanning the organization, and external partners. Collaborate with technical leaders for product design, development, integration, testing, and reliability improvements. Qualifications Must have a Bachelors of engineering or science. Post graduate degrees in Engineering is desired. 7 years of experience in regulated industry working on complex electromechanical systems. A strong technical background within Systems Engineering, Human Factors / Usability engineering, medical device development, or similar. Experience structuring, recruiting for, conducting, and reporting on formative and summative usability evaluations, especially involving class II medical devices. Strong understanding of Design Controls for medical device development. Experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, IEC 62366, and ISO 14971. Experience in using requirement management and Traceability tools such as Polarion, Jama, DOORS, etc. Technical leadership or program management experience. Strong understanding of project/program management with an understanding of the FDA product development process. Demonstrated experience in driving design for manufacturability and service. Significant Work Activities N/A Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC 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. 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.