West Pharma Manager Product Development 

United States, Arizona, Scottsdale 

358347885

Job Summary:

In this role, you will manage a drug delivery devices product development team; providing platform and customer product development, failure investigation, and post-market design sustainment for our portfolio of handheld and wearable drug delivery systems.

Essential Duties and Responsibilities:

• Lead technical team to 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.
• Provide support of product complaints and non-conformances to assess impact, determine root cause(s), and identify corrective and preventative actions.
• Understand product design history file contents and support customer and regulatory audits.
• Identify and evaluate opportunities, unmet needs, and requirements for new product / product line extension projects and/or product optimization development projects.
• Partner with senior leadership to establish, communicate, and drive platform product development and sustainment strategy including roadmaps and key capabilities.
• Identify and evaluate new tools and consulting services to support product and process development needs.
• Select, develop, and manage technical team ranging from early career to senior level to meet current and future needs.
• Interface with customers and external support services, e.g. suppliers and contract vendors, to facilitate the development and execution of assigned programs.
• Build, track, manage, and communicate project schedules to internal and external stakeholders to meet all deliverables on time.
• Review technical team deliverables including change control plans, project schedules, design controls, and communication for quality, accuracy, and technical soundness.
• Use sound engineering principles and critical thinking skills to make risk-based decisions and drive the completion of deliverables.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

Basic Qualifications:

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

Preferred Knowledge, Skills and Abilities:

• Demonstrated ability to:
  • Lead, prioritize, and complete multiple technical projects and daily tasks.
  • Lead and mentor others.
  • Facilitate and coach others through effective problem solving and decision making processes.
  • Understand and communicate technical ideas and concepts with technical and non-technical audiences (written and verbal).
  • Delegate and empower others while maintaining accountability to overall functional performance.
  • Work well with others in a variety of situations.
• Background in development or sustainment of electromechanical products.
• Broad experience in product development from early feasibility through commercialization and into sustainment including design controls, statistics, test method development, gauge R&R, human factors engineering, design verification, and design validation.
• Knowledge of ISO 11608, IEC 60601, ISO 14971, ISO 10993, and other relevant standards for medical devices.
• Experience influencing business and technical teams to adopt alternative ideas and methods.
• Knowledge of lean product and manufacturing concepts including design for manufacturability.
• Proficiency in MS Office Suite, Minitab, and DevOps.

Travel Requirements:

• Must be able to travel up to 10% of the time to domestic & international customers and West manufacturing locations as project requirements & business needs require.

Physical and Mental Requirements:

• Work in an office/home office environment. At times required sit or stand for extended periods of time.