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Sr. Manager, Device Engineering
Company | Pfizer |
Address | , , Ca |
Employment type | FULL_TIME |
Salary | $127,400 - $212,200 a year |
Expires | 2023-07-14 |
Posted at | 1 year ago |
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be responsible for marketed invitro diagnostic (IVD) 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 ensure the medical device design controls are documented in accordance to design control requirements.
This is an onsite position that will be located in San Jose or Emeryville, CA.
How You Will Achieve It
- Generate documentation to support regulatory filing and compliance.
- Write technical reports in accordance with Pfizer design control policies and procedures.
- Develop technical impact assessments for all changes and develop execution plan.
- Develop risk assessments, risk mitigation strategies and risk plan.
- Provide input and feedback on packaging concepts for new drug delivery systems to R&D.
- Establish experimental protocols, conducting experiments, analyzing results, and documenting the information.
- Facilitate, support, and/or execute verification of device components/system.
- Ensure project deliverables meet their quality, safety, and functional goals, and satisfy the customer.
- Provide technical leadership in the investigations of delivery system failures to determine root cause and implement appropriate corrective and preventive actions.
- Manage changes to delivery devices together with third party and internal Pfizer sites to meet regulatory requirements.
QUALIFICATIONS
Education:
- Masters in related field is preferred.
- Bachelor degree in Mechanical, Materials, Biomedical, Chemical or Manufacturing Engineering is required.
Experience:
- 5 years more in technical leadership or complex project.
- Minimum of 10 years in field related to medical device materials and high volume production is required.
- Drug container and/or drug-device combination product experience is preferred.
Other:
- Working knowledge of statistical methods for data analysis
- Experience in complying with EU Medical Device Directives and FDA Quality System Regulations
- An ability to work independently as well as a member of a team in a fast-paced environment
- Ability to develop communication networks across different functions and sites, both locally and globally.
- Practical experience working with a quality management system certified to ISO 13485.
- Understanding of manufacturing flow in a GMP regulated environment
- Ability to build effective relationships with customers and provide feedback on a timely basis
- Quick learning of new processes
- Ability to understand and analyze complex technical issues related to device design and manufacture
PHYSICAL/MENTAL REQUIREMENTS
Must be able to perform mathematical calculations and perform complex data analysis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel will be required for this job. You will travel up to 30% of the time
Other Job Details:
- Employee referral eligible: Yes
- Relocation assistance eligible: Yes
- Last Date to Apply: May 24, 2023
Relocation assistance may be available based on business needs and/or eligibility.
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.
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.
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