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Manager, Device Engineering

Pfizer


Location:
Peapack and Gladstone, NJ
Date:
11/04/2017
2017-11-042017-12-05
Pfizer
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Job Details

**ROLE SUMMARY**



You will be part of the Packaging & Delivery Systems group within Global Technology Services and be responsible for marketed combination product device lifecycle changes, troubleshooting and processing across the network. You will be responsible for developing device change technical impact assessments and risk assessments as well as developing verification plans, test methods and data analysis. You will be responsible for risk management activities. You will ensure the medical device design controls are documented in accordance to design control requirements.







**ROLE RESPONSIBILITIES**







+ Develop technical impact assessments for all changes and develop execution plan.



+ Manage changes to delivery devices together with third party and internal Pfizer sites to meet regulatory requirements.



+ Develop risk assessments, risk mitigation strategies and risk plan.



+ Write technical reports in accordance with Pfizer design control policies and procedures.



+ Facilitate, support, and/or execute verification of device components/system.



+ Establish experimental protocols, conducting experiments, analyzing results, and documenting the information.



+ Provide technical leadership in the investigations of delivery system failures to determine root cause and implement appropriate corrective and preventive actions.



+ Provide input and feedback on packaging concepts for new drug delivery systems to R&D.



+ Ensure project deliverables meet their quality, safety, and functional goals, and satisfy the customer.



+ Generate documentation to support regulatory filing and compliance.







**QUALIFICATIONS**



**Education:**







+ Bachelor degree in Mechanical, Materials, Biomedical, Chemical or Manufacturing Engineering is required.



+ Masters in related field is preferred.







**Experience:**







+ Minimum of 8 years in field related to medical device materials and high volume production is required.



+ 3 years more in technical leadership or complex project.



+ Drug container and/or drug-device combination product experience is preferred.







**Other** :







+ An ability to work independently as well as a member of a team in a fast-paced environment



+ Excellent interpersonal and communications skills with a good command of Swedish and English



+ Experience in complying with EU Medical Device Directives and FDA Quality System Regulations



+ Practical experience working with a quality management system certified to ISO 13485.



+ Understanding of manufacturing flow in a GMP regulated environment



+ Ability to develop communication networks across different functions and sites, both locally and globally.



+ Ability to build effective relationships with customers and provide feedback on a timely basis



+ Ability to understand and analyze complex technical issues related to device design and manufacture



+ Quick learning of new processes



+ Working knowledge of statistical methods for data analysis







**PHYSICAL/MENTAL REQUIREMENTS**







+ Must be able to travel







Must be able to perform mathematical calculations and perform complex data analysis







**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.







**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.







**Additional Offer Details:**







+ Last Date to Apply for Job: November 17, 2017



+ This job is Pfizer/Exempt (US/PR) Grade: 12



+ Eligible for Relocation Package



+ Eligible for Employee Referral Bonus







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