Principal Engineer, R&D

 

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 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

 

 

Basic Qualifications - Education: 

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

 

Basic Qualifications – 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