Allergan Principal Systems Engineer in Pleasanton, California
Principal Systems Engineer
Pleasanton, California, United States at https://agn.referrals.selectminds.com/jobs/5196/other-jobs-matching/location-only
May 29, 2018Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
The Principal Systems Engineer will implement best-in-class practices for translating user and business needs into system and subsystem requirements. The person shall be experienced in all aspects of product development with emphasis on systems engineering processes and leadership with a strong understanding of software, electrical and mechanical integration. The person will provide system concept definition, system requirements development and analysis, risk assessment, usability engineering, and systems integration. 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:
• Lead systems engineering activities for complex electro-mechanical medical devices.
• Translate customer needs, research findings and business requirements into product requirements and specifications.
• Ensure system design and appropriate supporting documentation meets all safety and regulatory compliance.
• Lead development and maintenance of product specifications, requirements documents, hazards analysis, design FMEA, usability, 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.
• Lead risk analysis, including system hazard analysis and design FMEA.
• Provide technical leadership for product design, development, integration, testing, and reliability improvements.
• Define usability evaluation plans and conduct and coordinate usability testing activities and ensure usability engineering is applied according to international standards
• Bachelors/Masters in Engineering with specialization in product development in medical equipment or capital equipment with 10 years of work experience
• 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.
• Requires at least 5 years of technical leadership or program management experience
• Strong understanding of system, electrical, and mechanical design, as well as software integration.
• Strong understanding of project/program management is required with an understanding of the FDA product development process. Familiarity of Solidworks or Pro-E, OrCAD and understanding of PLM are a plus.
• Demonstrated experience in driving design for manufacturability and service.
• Occasional travel, typically <15%, including car or domestic and international flights
• Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Allergan complies.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.