Principal Engineer, R&D, Integrated Systems

2 days ago

Exton, Pennsylvania, United States West Pharmaceutical Services, Inc. Full time
Job Summary

The R&D team within West's Glass Systems business is seeking a Principal R&D Engineer to lead design and development activities within West's Product Development Process. This role requires strategic thinking, leadership, and a goal-oriented approach to drive innovation and process efficiency in glass systems.

Key Responsibilities
  • Plan and execute projects through all phases, focusing on design and qualification through verification and validation.
  • Create and edit product models/drawings, write engineering test protocols, reports, and work instructions.
  • Lead technical reviews and design reviews, applying engineering principles for design/analysis of complex technical problems.
  • Drive innovation and process efficiency of glass systems, developing technical solutions to complex problems using sound engineering principles.
  • Develop robust test methods, design test fixtures, and execute measurement system analysis, plan, execute, and analyze design of experiments (DOE).
  • Write, implement, and lead bench studies, tolerance stack up analysis, design verification, validation, materials specifications, and component specifications.
  • Generate, record, and analyze data, and present results to peers and business leadership.
  • Integrate planning activities between West and development/manufacturing partners, working closely with Procurement to identify and qualify vendors.
Requirements
  • Bachelor's degree in Mechanical or Biomedical Engineering or equivalent experience.
  • Minimum 8 years of experience in medical device or Combination Product industry.
  • Expertise in medical device design control and change management, risk management, design verification & validation strategy development and execution.
  • Knowledge of applicable ISO, and USP standards for drug delivery, and health authority regulations including FDA, MDR.
  • Proficiency in Solid Modeling/Drafting, solid mechanics/mechanics of materials, statistical methods/tools, and project management.
Preferred Qualifications
  • Master of Science degree.
  • Experience with Combination Products requirements and regulation, high-volume, automated manufacturing processes, and glass forming.
  • Knowledge of Six Sigma (DMAIC) practices and Design for Six Sigma (DFSS) methodologies.
  • Ability to lead and teach others to assess project/program needs, formulate strategies, build support, and execute initiatives.
Work Environment

This role operates in a professional office environment and/or R&D lab, requiring the ability to stand or sit for extended periods, communicate effectively, and work well with others in a variety of situations.

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