Hybrid Senior Engineer, R&D

at West Pharmaceutical Services

• Job title: Senior Engineer, R&D
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Exton, United States

About the role

• Sr. Engineer in R&D at West supporting design and development of life-saving medicines. Collaborating with teams to deliver project goals and meet milestones in a hybrid role

Responsibilities

• Support design and development activities within West's Product Development Process
• Demonstrate accountability for the successful and timely achievement of goals
• Work independently only with strategic guidance in the most complex situations
• Interpret internal and external business issues and unmet needs
• Define/plan/lead/develop solutions
• Collaborate with local and global functional groups, stakeholders, and management to deliver project goals and meet project milestones
• Plan and execute projects through all phases with a focus on design and qualification through verification and validation
• Write engineering test protocols, reports, and work instructions
• Analyze design of experiments (DOE)
• Drive innovation and process efficiency of integrated systems
• Use sound principles to develop solutions for complex technical problems
• Generate, record and analyze data, and present results to peers and business leadership
• Point of contact for technical product related discussions with the team
• May provide technical expertise and communication for internal and external partners
• Integrate planning activities between West and development/manufacturing partners

Requirements

• Bachelor's Degree in Mechanical, Chemical or Biomedical Engineering required; or equivalent experience required
• Master's Degree in Mechanical or Biomedical Engineering preferred; or equivalent experience preferred
• Minimum 5 years Experience in regulated industry required or 5 years medical device or combination product industry highly preferred
• Experience in high-volume, automated manufacturing processes, and glass forming preferred
• Experience in Human Factors for Medical Devices preferred
• Expertise with test method development, validation strategy, and execution preferred
• Expertise with risk management, design verification and validation strategy development and execution
• Expertise in medical device design control and change management
• Experience with combination products requirements and regulation
• Proficiency in solid modeling/drafting
• Proficiency in solid mechanics/mechanics of materials
• Proficiency in statistical methods/tools
• 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

Benefits

• Supported by benefit programs
• Empower the physical, mental, emotional and financial health of our team members and their families
• Opportunities for lifelong learning, growth and development