Device 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 Hospital Medicine Business Unit specifically sterile injectables product, 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 supports Pfizer Global Supply (PGS) post-market maintenance activities such as risk assessment, change management, and technical support for regulatory inquiries.
This position is responsible for project planning, creating and maintaining user & product requirements and risk files, establishing and publishing traceability, and providing support to PGS on-market product support. In compliance with 21CFR 820 and corporate procedures, this position will be responsible for documentation generated in support of product development and submissions.
* Determines the DHF Structure and Owns the Requirements and Risk Management File. Primary responsibility for DHF content generation in support of regulatory submissions with compliance to governing procedures, ISO 14971 and 21CFR 820.30 Design Control. Partner 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 to instill a spirit of collaboration throughout the organization. Generates risk documents relating to use tasks and working closely with human factors in formative and summative study protocol generation.
* Integrates multiple approaches to solve problems or optimize solutions in complex or cross functional manufacturing processes or product designs. Creates/modifies subsystems' designs for complex problems. Integrates subsystems and components in total systems designs; develops specifications from customer requirements.
* BS and 4-5 yrs experience medical device or combination product industry or MS in Biomedical, Materials, Mechanical, Industrial Engineering and 1-3 yrs experience in medical device or combination product industry
* Understanding of FDA and EU regulations. Working knowledge of CFR 820.30 Design Controls and ISO 14971 Application of Risk Management to Medical Devices
* Previous combination products or drug delivery experience. Systems Engineering experience and working knowledge of medical plastics. Experience with DOORS requirements management software. Working knowledge of ISO 13485
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Other Job Details:
* Last Date to Apply for Job: March 22, 2019
* 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.
Associated topics: equipment, http, information architect, infrastructure architect, ip, maintenance, senior engineer, senior system engineer, system architect, system integrator