Senior Engineer, R&D
West Pharmaceutical Services
full-time
Posted on:
Location Type: Hybrid
Location: Exton • Pennsylvania • United States
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Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Mechanical EngineeringChemical EngineeringBiomedical EngineeringTest Method DevelopmentValidation StrategyDesign VerificationDesign ControlSolid ModelingStatistical MethodsRisk Management
Soft Skills
Interpersonal SkillsDecision-Making SkillsChange ManagementProblem SolvingCollaborationCommunicationAccountabilityInnovationProcess EfficiencyLeadership