Pfizer Careers – Sr Biomedical Engineer

Job Description:

Performs 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. Designs, develops, and/or fabricates test fixtures/test items. Writes SOPs, test protocols and laboratory research reports as needed. Document laboratory testing protocols and results as per corporate policies. Performs research in market assessment or clinical and user studies. Responsible for documenting development work in a Design History File for all product development.

Job Responsibilities:

• Perform engineering testing
• Conduct research and user simulator development and assembly
• Conceptual design of new drug delivery systems or product enhancements
• Develop engineering prototypes of design concepts
• Create engineering and development documentation such as product requirements, detail drawings, assembly drawings, tolerance stack analyses, change orders, risk analyses, etc.
• Write test protocols, reports and drafts technical presentations and test plans
• Design test fixtures or component
• Comply with FDA Regulation and Guidance for Combination Products

Job Requirements:

• Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.
• Strong mathematical, analytical, and reasoning skills
• Rapid prototype modeling including use and maintenance of 3-D printers
• Experience 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
• Being able to prioritize multiple responsibilities and to work on multiple tasks simultaneously
• Responds to requests for service and assistance with professionalism, courtesy, and confidence
• B.S. Degree in Engineering discipline with 2 – 4 years experience
• Associate Degree in Engineering discipline with 4 – 6 years experience

Job Details:

Company: Pfizer

Vacancy Type: Full Time

Job Location: Washington, DC, US

Application Deadline: N/A

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