About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
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 project planning, creating and maintaining product requirements and risk files, establishing and publishing traceability, and providing for on-market support and maintenance. In compliance with CFR 820 and corporate procedures, this position will be responsible for documentation generated in support of product development and submissions, and may also be responsible for on-market product documentation.
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 and CFR 820.30
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.
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 -3 yrs exp. MS and -1 yrs exp. Engineering discipline or equivalent experience. Biomedical, Materials, Mechanical, Industrial Engineering degree preferred
Preferred: 3 years systems engineering experience, working knowledge of medical plastics. Experience with DOORS requirements management software.
Required: Understanding of FDA and EU regulations. Working knowledge of CFR 820.30 Design Controls and ISO 14971.
EEO & Employment Eligibility
the company 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. the company 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. the company is an E-Verify employer.
A little about us:
Join Pfizer in our mission to find sustainable solutions to the most urgent health care challenges of our time. Your service is needed.