Principal Engineer, R&D, Integrated Systems

This position is hybrid in Exton, PA. Candidates applying must be residing within a 50 miles radius to the job location.

 

Who We Are: 

 

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

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 & 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, 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 
• Develops technical solutions to complex problems using sound engineering principles, utilizing 
experimental, computational, and analytical methods 
• Applies innovative & logical risk-based approach to product development challenges with the capacity for 
original thinking. Develops robust test methods, design test fixtures and execute measurement system 
analysis 
• Plans, executes, and analyzes design of experiments (DOE) 
• Writes, implements and leads bench studies, tolerance stack up analysis, design verification, validation, 
materials specifications and component specifications. 
• Generates, records and analyzes data, presents results to peers and business leadership 
• Integrates planning activities between West and development/manufacturing partners 
• Works closely with Procurement to identify and qualify vendors ensuring appropriate components are 
procured and delivered as needed throughout the phased development process 
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules 
• Other duties as assigned   

Education

• Bachelor's Degree in Mechanical or Biomedical Engineering required and
• Master's Degree In Mechanical or Biomedical Engineering preferred

Work Experience

• Minimum 8 years in medical device or Combination Product industry required and
• Experience in high-volume, automated manufacturing processes, and glass forming preferred
• Strong interpersonal and decision-making skills and the ability to effectively manage change and
  uncertainty 
• Expertise in medical device design control and change management is required
• Expertise with Risk Management, Design Verification & Validation strategy development and execution is 
  required 
• Expertise with test method development, validation strategy, and execution is required  
• Knowledge of applicable ISO, and USP standards for drug delivery 
• Knowledge of applicable health a