1+ months

Senior Biomedical Engineer

Pfizer
Columbia, MD 21044
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  • Jobs Rated
    30th
**ROLE SUMMARY**

Works as a biomedical engineering team member on cross-functional teams throughout the development process. Performs or oversees biomedical/mechanical engineering, design, and development work. Develops design concepts and ideas for new products and product improvements. Develops prototypes of design concepts for engineering testing and evaluation. Reviews/approves SOPs, test protocols, laboratory research reports and provides laboratory oversight as needed. Performs human factors (usability studies), market assessment, or pre-clinical research. Responsible for adhering to design controls and documenting all product development work in a Design History File.



**ROLE RESPONSIBILITIES**



+ Conceptual design of new drug delivery systems or product enhancements for pre-hospital emergency care products

+ Develop design inputs with associated justification for new product development

+ Develop engineering prototypes of design concepts

+ Lead risk analysis activities

+ Develop project plans and budgets

+ Approve test protocols and reports

+ Conduct research and publish as appropriate

+ Technical oversight of Biomedical and Associate Biomedical Engineers

+ Comply with FDA Regulation and Guidance for Combination Products



**BASIC QUALIFICATIONS**



+ B.S. Degree in Engineering discipline with 5 - 7 years experience

+ M.S. Degree in Engineering discipline with 3 - 5 years experience

+ Ph.D. in Engineering discipline with 1 - 3 years experience



(Biomedical Engineering or Mechanical Engineering preferred)



**PREFERRED QUALIFICATIONS**



+ Conceptual design skills and experience with a variety of manufacturing methods (e.g. injection molding, machining, etc.)

+ Human factors and usability engineering

+ Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.

+ Strong laboratory skills such as component inspection or failure analysis, mechanical testing, etc.

+ Strong mathematical, analytical, and reasoning skills

+ Strong problem solving skills

+ Strong innovation skills

+ Strong creativity astuteness

+ Strong research skills

+ Strong organizational skills

+ Strong in team work

+ Strong written and oral communication

+ Experience in complying with FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30 and EU Medical Device Directives

+ Ability to prioritize multiple responsibilities and to work on multiple projects simultaneously

+ Business acumen - demonstrates knowledge of market and competition

+ Responds to requests for service and assistance with professionalism, courtesy, and confidence

+ Laboratory management experience



**PHYSICAL/MENTAL REQUIREMENTS**

The employee is regularly required to sit, talk or hear, stand and walk. Lifting boxes of 20 lbs. Specific vision abilities required by this job include ability to adjust focus. The noise level in the work environment is usually moderate.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ Must be able to travel 25% of the time.

+ Position requires regular onsite attendance, however, this position may be performed on a remote or telecommute basis on a temporary, short term basis.

+ Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

+ Must have the ability to work effectively under and manage to strict production, time and performance deadlines.

+ Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.



The job is open only to Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.



Last Date to Apply for Job: May 15, 2020

Eligible Employee Referral Program

Eligible for Relocation Package



**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.



Research and Development

Jobs Rated Reports for Biomedical Engineer

Posted: 2020-04-21 Expires: 2020-07-23
Sponsored by:
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Senior Biomedical Engineer

Pfizer
Columbia, MD 21044

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Biomedical Engineer
30th2018 - Biomedical Engineer
Overall Rating: 30/220
Median Salary: $88,040

Work Environment
Very Good
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Stress
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73/220
Growth
Poor
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