Sr. Device Engineer

PfizerParsippany, NJ
Hybrid

About The Position

This role has primary responsibility for confirmation that medical devices and drug/device combination products meet their intended function. This includes development of data through engineering studies that informs new product development as well as test reports that support product submissions. The candidate will work within a team environment to solve problems and utilize best engineering practices and techniques for root cause and statistical analysis. This work entails defining test methods, developing protocols, performing data analysis, and writing reports in compliance with corporate procedures.

Requirements

  • Bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
  • Permanent work authorization in the United States.

Nice To Haves

  • Experience in the pharmaceutical or biotechnology industry
  • Familiarity with Good Manufacturing Practices (GMP)
  • Experience with statistical software (e.g., Minitab, JMP)
  • Ability to lead cross-functional teams
  • Strong organizational skills
  • Adaptability and flexibility in a dynamic work environment
  • Ability to mentor and develop junior team members
  • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
  • Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Responsibilities

  • Partner with Systems engineers in defining product requirements such that they are verifiable
  • Development of test fixtures, test methods, and performance of Test Method Validation activities
  • Coordinate with internal and external partners and suppliers to procure test samples and manage conditioning and accelerated aging studies
  • Ensure integrity and compliance of data according to Standard Operating Procedures
  • Develop Verification Plans including test strategy
  • Utilize technical writing and statistical data analysis skills to write protocols and reports
  • As necessary, conduct root cause analysis and derive recommendations based on analysis of data
  • Translate inspections and tests methods into component and product specifications
  • Potential for Project Team lead responsibilities including MS Project schedule creation/maintenance, device team meetings, and overall team management.

Benefits

  • 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
  • paid vacation, holiday and personal days
  • paid caregiver/parental and medical leave
  • health benefits to include medical, prescription drug, dental and vision coverage
  • Relocation assistance may be available based on business needs and/or eligibility.
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