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Hospira, a Pfizer company, is the global leader of injectables drugs and infusion technologies, committed to putting patients first by improving access and care worldwide.THE ROLE:Differentiated Drug Delivery (DDD) is a drug device combination design and development organization focused on improving patients' lives through customer-focused innovation and broad-based access to quality medicines and products. Supporting the Pfizer Essential Health business unit (formerly Pfizer's Global Established Pharmaceutical (GEP) organization) specifically the sterile injectables products, the Systems Engineering function has the primary responsibility for developing Design History File (DHF) documentation for ensuring compliance to CFR 820.30 Design Controls and risk management per ISO 14971 for the device constituent and drug-device interfaces of combination products. The Systems Engineering team owns deliverables that document safety and efficacy for new product submissions and also provide for post-market risk assessment and change control. The Systems Engineering function has primary responsibility for developing Design History File (DHF) documentation for ensuring compliance to CFR 820.30 Design Controls and risk management per ISO 14971 for the device constituent and drug-device interfaces of combination products. The Systems Engineering team owns deliverables that document safety and efficacy for new product submissions and also post-market maintenance activities such as risk assessment, change management, and technical support for regulatory inquiries.This position is responsible for end-to-end product life cycle management including creating and maintaining product requirements and risk files, establishing and publishing traceability, and providing for on-market support and maintenance for newly launched products. In compliance with CFR 820 and corporate procedures, this position will be responsible for documentation generated in support of product development and submissions.ROLE SUMMARYDevice and Combination Product (DCP) is a drug device combination design and development organization focused on improving patients' lives through customer-focused innovation and broad-based access to quality medicines and products. Supporting the Pfizer Hospital business unit primarily sterile injectables products, the Systems Engineering function has the primary responsibility for developing Design History File (DHF) documentation for ensuring compliance to CFR 820.30 Design Controls and risk management per ISO 14971 for the device constituent and drug-device interfaces of combination products. The Systems Engineering team owns deliverables that document safety and efficacy for new product submissions and also provide for post-market risk assessment and change control.The Principal Systems Engineer is responsible for all aspects of systems engineering including project planning, creating and maintaining user/product requirements and risk files, mentoring junior engineers, establishing and publishing the traceability between all aspects of product definition and risk management for assigned differentiated drug delivery (drug device combination) products. S/he will work collaboratively with a cross-functional team with an emphasis on delivering a set of requirements that will drive design outputs, Human Factors activities, as well as the acceptance criteria for Design Verification and Design Validation, and ultimately the DHF elements that are transferred to manufacturing. Determines the DHF Structure and owns the Requirements and Risk Management File. Primary responsibility for DHF content for compliance to governing procedures and CFR 820.30 including management of complex product configurations and platforms. Interfaces with commercial and medical colleagues to drive clarity and documentation for product user needs, use environment, and system actors within the product life cycle. Partners with other functions in the organization to ensure stakeholders' requirements are addressed and met as appropriate; to provide consistent direction to cross functional teams and mentorship/guidance to junior engineers in new product development. Responsible for independently leading and researching product requirements including alignment to consensus standards, relevant agency guidance, and Design Verification methodology to ensure testable and consistent product definition. Responsible for medical device risk management per ISO 14971, including the analysis of interactions and risk assessment of drug-device interfaces. Develops a comprehensive assessment and report of Use, Design, and Process risk and mitigation to create the Risk Management Report. Provides evidence of DHF completeness and alignment through management of traceability utilizing industry best practices and technology. Supports the generation of regulatory submission documentation and as necessary support internal and external audits. Ensures high quality deliverables in compliance with regulation and local procedures. Provides leadership to the Systems team in developing advanced concepts, techniques, and standards. Maintains current knowledge of industry best practices and technological trends. Participates in cross-functional team and represents as functional leader to continuous improvement initiatives to establish processes and solve complex problems. Works within multi-disciplinary teams within DCP. Interfaces with core teams within DCP, Regulatory and QA groups, Pfizer Global Supply (PGS), Pfizer Commercial, Pfizer clinical groups and other groups within Pfizer involved in device development.BASIC QUALIFICATIONS Bachelors of Science in Engineering (Chemical Engineering, Biomedical Engineering, Mechanical Engineering) or science discipline and 7+ years of experience; or Masters of Science and 4-8 years of experience; or PhD and minimum of 3 years of experience.PREFERRED QUALIFICATIONS
Medical device industry preferred; other regulated industries such as aerospace may be considered.
Understanding of FDA and EU regulations. Expert working knowledge of CFR 820.30 Design Controls and ISO 14971.
Previous experience in combination products risk management.
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Eligible for Employee Referral Bonus
N (Other) (United States of America)Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Vacancy caducado!