Posted:
11/13/2024, 4:00:00 PM
Location(s):
New Jersey, United States ⋅ Parsippany-Troy Hills, New Jersey, United States
Experience Level(s):
Senior
Field(s):
Data & Analytics
Role Summary:
This role has primary responsibility for confirmation that medical devices and drug/device combination products meet their intended function. This includes development of data through engineering studies that informs new product development as well as test reports that support product submissions. The candidate will work within a team environment to solve problems and utilize best engineering practices and techniques for root cause and statistical analysis. This work entails defining test methods, developing protocols, performing data analysis, and writing reports in compliance with corporate procedures.
Role Responsibilities:
Partner with Systems engineers in defining product requirements such that they are verifiable
Development of test fixtures, test methods, and performance of Test Method Validation activities
Coordinate with internal and external partners and suppliers to procure test samples and manage conditioning and accelerated aging studies
Ensure integrity and compliance of data according to Standard Operating Procedures
Develop Verification Plans including test strategy
Utilize technical writing and statistical data analysis skills to write protocols and reports
As necessary, conduct root cause analysis and derive recommendations based on analysis of data
Translate inspections and tests methods into component and product specifications
Potential for Project Team lead responsibilities including MS Project schedule creation/maintenance, device team meetings, and overall team management.
Qualifications:
B.S. in Engineering discipline and minimum 5 years related experience.
MS in Engineering degree and minimum 3 years related experience.
PhD in Engineering and minimum 1-year related experience.
Familiarity with ISO standard test methods and related test instrumentation preferred. Excellent analytical and communication skills required.
Ability to work and solve problems in team environment.
Technical writing skills are required for protocol and report writing.
PHYSICAL/MENTAL REQUIREMENTS
This position requires the typical physical demands of a general scientific laboratory environment with respect to generally standing during experimental execution and sitting and working at a computer during documentation of work.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
5-10% travel based on business need
ability to perform mathematical calculations and ability to perform complex data analysis.
Work Location Assignment: On premise, with relocation support available
PHYSICAL/MENTAL REQUIREMENTS
This position requires the typical physical demands of a general scientific laboratory environment with respect to generally standing during experimental execution and sitting and working at a computer during documentation of work.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
5-10% travel based on business need
ability to perform mathematical calculations and ability to perform complex data analysis.
Work Location Assignment: On premise, with relocation support available
Relocation support available
Work Location Assignment: Hybrid
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. This position requires permanent work authorization in the United States.
Website: https://www.pfizer.com/
Headquarter Location: New York, New York, United States
Employee Count: 10001+
Year Founded: 1849
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine