Biomedical Engineer United States - Maryland - Columbia/en-US/PfizerCareers/job/United-States---Maryland---Columbia/Biomedical-Engineer_4715465-1/apply ROLE SUMMARY Provides biomedical engineering support for cross-functional development teams throughout the development process.nbsp; Performs biomedical/mechanical engineering, design, and development work.nbsp; Develops engineering prototypes of design for engineering testing and evaluation.nbsp; Designs, develops, and/or fabricates test fixtures/test items.nbsp; Writes SOPs, test protocols and laboratory research reports as needed. Document laboratory testing protocols and results as per corporate policies. Provides support for human factors (usability studies) research or other development related research as required.nbsp; Responsible for adhering to design controls and documenting all product development work in a Design History File. ROLE RESPONSIBILITIES * Detailed engineering design including tolerance stackups * 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. * Conceptual design of pre-hospital emergency care products, drug delivery systems, or product enhancements * Write test protocols, perform engineering testing, and write reports * Conduct research and publish as appropriate * Design test fixtures or components * Comply with FDA Regulation and Guidance for Combination Products BASIC QUALIFICATIONS * nbsp;B.S. Degree in Engineering discipline with 3 5 years experience * M.S. Degree in Engineering discipline with 1 3 years experience * Ph.D. in Engineering discipline with 0 1 years experience (Biomedical Engineering or Mechanical Engineering preferred) PREFERRED QUALIFICATIONS * Conceptual design skills * Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc. * Familiar with various manufacturing methods (e.g. injection molding, machining, casting, etc.) * Familiar with various inspection and test methods * Strong mathematical, analytical, and reasoning 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 tasks simultaneously * Responds to requests for service and assistance with professionalism, courtesy, and confidence PHYSICAL/MENTAL REQUIREMENTS The employee is regularly required to sit, talk or hear, stand and walk.nbsp; Lifting boxes of 20 lbs. nbsp;Specific vision abilities required by this job include ability to adjust focus.nbsp; 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.nbsp; 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. ORGANIZATIONAL RELATIONSHIPS * Director of Biomedical Technology * Senior Director of Biomedical Technology * Associate Biomedical Engineers, Sr. Biomedical Engineers, and Principal Biomedical Engineers * Cross-functional teams of various disciplines within Pfizer/Meridian * CROs as required RESOURCES MANAGED Supervision May provide training for new hires or contractors and may oversee work conducted by contractors or lab technicians EEO amp; 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.nbsp; Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment.nbsp; 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. 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 providers name, address and the type of payments or other value received, generally for public disclosure.nbsp; 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.nbsp; 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.nbsp; If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. * Last Date to Apply for Job: September 14, 2018 * Eligible for Relocation Package Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Posted 5 Days AgoFull time4715465 A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. nbsp;Pfizer, a global leader in the bio pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. nbsp;