West Pharmaceutical Services - Scottsdale, AZ

posted 22 days ago

Full-time - Manager
Scottsdale, AZ
Professional, Scientific, and Technical Services

About the position

The Manager of Product Development at West will lead a team focused on the development of drug delivery devices, ensuring compliance with industry standards and regulatory requirements. This role involves managing product design history, supporting product complaints, and driving product development strategies in collaboration with senior leadership. The position emphasizes the importance of teamwork, technical expertise, and effective communication to enhance product offerings and meet customer needs.

Responsibilities

  • Manage a drug delivery devices product development team.
  • Define, drive, and manage changes to the product design history file.
  • Lead product review and impact assessments to industry standards, customer contracts, and regulatory requirements.
  • Support product complaints and non-conformances to assess impact and determine root causes.
  • Understand product design history file contents and support customer and regulatory audits.
  • Identify and evaluate opportunities for new product development and product optimization projects.
  • Partner with senior leadership to establish and communicate product development strategies.
  • Identify and evaluate new tools and consulting services for product development needs.
  • Select, develop, and manage a technical team to meet current and future needs.
  • Interface with customers and external support services to facilitate program execution.
  • Build, track, manage, and communicate project schedules to meet deliverables.
  • Review technical team deliverables for quality, accuracy, and technical soundness.
  • Make risk-based decisions using sound engineering principles.

Requirements

  • Bachelor's degree in Engineering or a related technical field, or equivalent experience.
  • Minimum 8 years of experience in an engineering capacity.

Nice-to-haves

  • Demonstrated ability to lead and mentor others.
  • Facilitate and coach others through effective problem-solving processes.
  • Understand and communicate technical ideas to both technical and non-technical audiences.
  • Background in development or sustainment of electromechanical products.
  • Broad experience in product development from feasibility through commercialization.
  • Knowledge of ISO 11608, IEC 60601, ISO 14971, ISO 10993, and other relevant standards for medical devices.
  • Experience influencing teams to adopt alternative ideas and methods.
  • Knowledge of lean product and manufacturing concepts.

Benefits

  • Opportunities for lifelong learning, growth, and development.
  • Support for physical, mental, emotional, and financial health of team members and their families.
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