West Pharma Principal Engineer R&D Integrated Systems 

United States, Pennsylvania, West Whiteland Township 

753134907

Job Summary:

The R&D team within West’s Glass Systems business is seeking a Principal R&D Engineer. In this role you will lead design and development activities within Wests Product Development Process demonstrating leadership and strategic thinking within a goal-oriented organization. The incumbent will:

1. Demonstrate accountability for the successful and timely achievement of goals
2. Work independently only with strategic guidance in the most complex situations
3. Interpret internal and external business issues and unmet needs and take a broad perspective to define/plan/lead/develop solutions.

Essential Duties and Responsibilities:

• Plan and execute projects through all phases with a focus 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
• Apply engineering principles for design/analysis of complex technical problems
• Drive innovation and process efficiency of glass systems
• Develop technical solutions to complex problems using sound engineering principles, utilizing experimental, computational, and analytical methods
• Apply innovative and logical risk-based approach to product development challenges with the capacity for original thinking. 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 presents results to peers and business leadership

• Integrates planning activities between West and development/manufacturing partners
• Work closely with Procurement to identify and qualify vendors ensuring appropriate components are procured and delivered as needed throughout the phased development process
• Other duties as assigned

Education:

• Bachelor’s degree in Mechanical or Biomedical Engineering or equivalent experience

Work Experience:

• Minimum 8 years of experience in medical device or Combination Product industry
• Expertise in medical device design control and change management
• Expertise with Risk Management, Design Verification & Validation strategy development and execution
• Expertise with test method development, validation strategy, and execution
• Knowledge of applicable ISO, and USP standards for drug delivery
• Knowledge of applicable health authority regulations including FDA, MDR
• Proficiency in Solid Modeling/Drafting
• Proficiency in solid mechanics/mechanics of materials
• Proficiency in statistical methods/tools
• Proficiency in project management

Preferred Knowledge, Skills and Abilities:

• Master of Science degree
• Experience with Combination Products requirements and regulation
• Experience in high-volume, automated manufacturing processes, and glass forming
• Experience in Human Factors for Medical Devices
• 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
• Strong interpersonal and decision-making skills and the ability to effectively manage change and uncertainty
• Knowledge of applicable ISO, and USP standards for drug delivery
• Knowledge of applicable health authority regulations including FDA, MDR
• Able to comply with the company’s safety and quality policies at all times

Travel Requirements:

• Must be able to travel up to 30% of the time

Physical Requirements:

• Job demand classification is Sedentary -exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.

Additional Requirements:

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment and/or R&D lab. May stand or sit for extended periods of time

• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand strategic direction, adhere to procedures and make contributions to strategy formation
• Organizational skills will enable planning, prioritization & and achievement of goals, especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, prioritize and make timely decisions
• Ability to deal with ambiguity and make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Reliable and predictable attendance
• Sensitivity for IP protection
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety and quality rules