Sr. Development Engineer II

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
Last date to apply June 18, 2024

The annual base salary for this position ranges from $88,300.00 to $147,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Research and Development