1+ months

Principal Biomedical Engineer

Pfizer
Columbia, MD 21044
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**ROLE SUMMARY**

Provide technical leadership on cross-functional teams throughout the development process from concept through commercialization. Develops design concepts and ideas for new products and product improvements. Oversees biomedical/mechanical engineering, design, and development work on assigned projects including prototyping and testing and evaluation. Manages CROs and performs human factors (usability studies), market assessment, or clinical research. Works with Business Development to explore acquisition or partnership opportunities. Works with Regulatory to develop strategy for product submissions and approvals. Responsible for adhering to design controls and documenting all product development work in a Design History File.



**ROLE RESPONSIBILITIES**



+ Provide technical leadership to Biomedical Engineers and cross-functional teams within Meridian/Pfizer

+ 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

+ Lead risk analysis and risk management activities including human factors studies

+ Approve designs, test protocols, and reports

+ Justify new product development and develop project plans and budgets

+ Conduct business development research and due diligence activities

+ Conduct research and publish as appropriate

+ Comply with FDA Regulation and Guidance for Combination Products



**BASIC QUALIFICATIONS**



+ B.S. Degree in Engineering discipline with 13+ years experience

+ M.S. Degree in Engineering discipline with 10 years experience

+ Ph.D. in Engineering discipline with 7 years experience



(Biomedical Engineering or Mechanical Engineering preferred)



**PREFERRED QUALIFICATIONS**



+ Excellent leadership, interpersonal, and organizational skills

+ Conceptual and creative design skills

+ Human factors and usability engineering experience

+ Experience with various manufacturing methods such as injection molding, metal stamping, machining, etc.

+ Strong mathematical, analytical, and reasoning skills

+ Strong innovation skills

+ Strong creativity astuteness

+ Strong problem solving skills

+ Strong research skills

+ Strong in team work

+ Strong written and verbal communication and presentation skills. Must be able to communicate effectively with staff at all levels in the organization.

+ Strong business acumen - demonstrates knowledge of market and competition

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

+ 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

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



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: March 31, 2020

Eligible for Relocation Package

Eligible Employee Referral Program



\#LI



**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
Posted: 2020-02-18 Expires: 2020-04-05

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Principal Biomedical Engineer

Pfizer
Columbia, MD 21044

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