Sign In
 [New User? Sign Up]
Mobile Version

Sr Systems Engineer, Medical Device, Risk Management

Pfizer


Location:
Lake Forest H4, IL
Date:
09/22/2017
2017-09-222017-10-21
Job Code:
1052138
Pfizer
Apply on the Company Site
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

Job Title Sr Systems Engineer, Medical Device, Risk Management

JobID 1052138

Location: Lake Forest H4, IL

Description A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer 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. Pfizer, 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.



Hospira, a Pfizer company, is the global leader of injectable 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 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 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 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.



QUALIFICATIONS



+ BS and 4-5 yrs exp., or MS and 3-5 yrs exp. Engineering discipline or equivalent experience. Biomedical, Materials, Mechanical, Industrial Engineering degree preferred

+ Preferred: Systems Engineering experience and 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.



Legacy Hospira Grade 16

Eligible for Employee Referral Bonus

Eligible for Relocation Package



EEO Statement

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.



II. Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

A career at Pfizer offers opportunity, ownership and impact.



All over the world, Pfizer 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. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


Apply on the Company Site
Powered By

Featured Jobs[ View All ]

Featured Employers [ View All ]