Pfizer

Senior Associate Device Engineer

Employer
Pfizer
Location
Columbia, Maryland
Salary
Competitive
Posted
April 28 2021
Ref
4811988
Position Type
Full Time
Organization Type
Pharma
ROLE SUMMARY

Works as a device engineering team member on cross-functional teams throughout the development product life cycle process. Supports device life cycle change management of on-market combination products. Develops change management technical impact assessments, design and development plans, risk management and design verification plans, test methods and data analysis. Performs biomedical/mechanical engineering, design, and development work. Develops design concepts and ideas for new products and product improvements, fixtures, gages, and test methods. Develops prototypes of design concepts for engineering testing and evaluation. Generates SOPs, test protocols, laboratory research engineering test reports and provides laboratory support as needed. Performs human factors (usability studies), market assessment, or pre-clinical research. Responsible for adhering to design controls and documenting all product life-cycle development work and updates in a Design History File.

ROLE RESPONSIBILITIES
  • Conceptual design of new drug delivery systems or product enhancements for on-market pre-hospital emergency care products
  • Develop test methods, fixtures, gages, challenge samples, limit samples, simulation devices, and 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 and execute test protocols and reports
  • Comply with FDA Regulation and Guidance for Combination Products
  • Review and execute device and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and device design integrity is maintained
  • Execute design change projects with guidance and according to internal procedures, track progress, and communicate status to group leadership
  • Support development and maintenance of DHF documents and rationales in support of new product development, remediation, information requests, and product life cycle
  • Represent group and product on Process Monitoring Team
  • Support Manufacturing, QCD Lab, QDS Lab, Quality Engineering and Quality Assurance with investigations and the qualification of material / processes / changes to assure reliability requirements are met, with guidance and supervision; participate in MDCP CAPAs.
  • Create engineering and development documentation such as product requirements, detail drawings, assembly drawings, tolerance stack analyses, change orders, risk analyses, etc. Establish and review specifications / requirements for components, products and processes, with guidance and supervision
  • Other duties as assigned


BASIC QUALIFICATIONS
  • B.S. Degree in Engineering discipline with 1 - 4 years experience
  • Associate Degree in Engineering discipline with 3 - 5 years experience
  • (Biomedical Engineering or Mechanical Engineering preferred)


PREFERRED QUALIFICATIONS
  • Demonstrated knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products
  • Experience analyzing patient/user impact
  • Experience in a GMP regulated industry
  • Ability to work independently as well as a member of a team in a fast-paced environment
  • Working knowledge of statistical methods for data analysis
  • Conceptual design skills
  • Proficiency in design software (preferably Solidworks), Mathcad, MindManager, and other general computer software such as word processing, spreadsheets, presentations, flow charts, etc.
  • Strong mathematical, analytical, and reasoning skills
  • Innovation skills and creativity astuteness
  • Critical thinking and problem solving skills
  • Strong team work and 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 written and oral communication
  • 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, ISO 13485, ISO 1497, and related standards
  • 2 years' experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality role


PHYSICAL/MENTAL REQUIREMENTS

While performing the duties of this job, the employee is exposed to general laboratory and/or manufacturing areas; work near moving mechanical parts; toxic or caustic chemicals; the noise level in the work environment is usually moderate; required to stand; walk; sit; talk or hear; lift and/or move up to 25 pounds
  • Laboratory testing or measurements required which may include some repetitive tasks or hand movements.
  • Specific vision abilities required by this job include ability to adjust focus
  • Able to coordinate and work on several projects at the same time, prioritizing work load appropriately and using time efficiently. Adapts quickly to changes in priorities or assigned work.
  • Self-motivated and safety-minded. Follows tasks through to completion in a timely manner with minimum supervision. Consistently produces high quality work. Able to focus on priorities and have a sense of urgency.
  • Good leadership and communication skills, works well with others, good mentor to others.
  • Professional and courteous. Open to other points of view, cordial and willing to accept feedback.
  • Good documentation practices. Able to work in a fast paced environment with good attention to detail. Right the first time approach.
  • Listens/ asks for clarification when needed


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Position requires the ability to attend on site as needed at either at the St. Louis, MO or Columbia, MD site; this position may be performed on a remote or telecommute basis as project work allows with manager approval
  • 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.
  • Occasional out-of-town travel may be required, as well as travel between the Westport and Brentwood facilities in St. Louis


The job is open only to Protected Individuals (as defined by 8 U.S.C. ยง 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 11, 2021

Eligible for Employee Referral Program

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.

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