Senior System Engineer - International Submission Support
Employment Type: Full-Time
Industry: Information Technology
AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter, Facebook or LinkedIn .
The Senior Systems Engineer, Submission Support, shall be responsible for supporting the international registration and testing of the Coolsculpting body contouring products. The person shall be experienced in all aspects of product development with emphasis on systems engineering processes with a strong understanding of a complex electro-mechanical system with software. The person will work closely with the project teams throughout the development process from User Needs definition, system design requirements development, risk assessment, software, and systems integration, as well as testing, to support timely and efficient product registrations. 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, support the systems engineering activities for complex electro-mechanical medical devices with specific responsibilities for international compliance.
- Work closely with Global Regulatory Lead (GRL) and International Regulatory teams throughout the Product Development process and into sustaining.
- Ability to understand and maintain compliance to international standards deviations and/or additional requirements.
- Ability to build test fixtures, generate test methods to support compliance testing.
- Support test labs with testing of new products and/or legacy products for compliance to international standards.
- Ensure system design and appropriate supporting documentation meets all safety and domestic and/or international regulatory compliance.
- Develop and maintain product specifications, requirements documents, risk documents, design V&V documentation, and other technical documentation.
- 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.
- Tailor testing reports/technical data and author relevant documents to meet international requirements as needed.
- Duties include around 30% domestic and/or international travel.
- 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.
- Strong understanding of Design Controls for medical device development.
- Strong understanding of project/program management is required with an understanding of the FDA product development process and understanding of PLM are a plus.
- Bilingual Preferred
Equal Employment Opportunity
- Bachelor's/Master's Degree in Engineering with specialization in medical device development with 5 years of relevant work experience
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.
Associated topics: equipment, http, ip, maintain, network, principal systems engineer, senior system engineer, server, system architect, systems integration architect
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