Senior Associate Biomedical Engineer

ROLE SUMMARY:

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.

ROLE RESPONSIBILITIES:

• 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
• Perform engineering testing
• Conduct research and user simulator development and assembly
• Design test fixtures or component
• Comply with FDA Regulation and Guidance for Combination Products

BASIC QUALIFICATIONS:

• B.S. Degree in Engineering discipline with 2 - 4 years experience
• Associate Degree in Engineering discipline with 4 - 6 years experience

(Biomedical Engineering or Mechanical Engineering preferred)

PREFERRED QUALIFICATION:

• Conceptual design skills
• Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.
• Strong mathematical, analytical, and reasoning skills
• Good innovation skills
• Strong Creativity astuteness
• Problem solving skills
• Good research skills
• Good organizational skills
• 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
• Strong in team work
• Strong oral communication
• Strong written communication
• 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

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: June 24, 2021

Sunshine Act

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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

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