The Principal Engineer will be responsible for leading the execution to the development of Pharmaceutical Container Systems in alignment with the overall R&D strategy starting at conceptualization and through development and transfer to manufacturing. The Engineer will be the lead subject matter expert responsible for analyzing new and emerging markets for system definition, appropriate standards and product requirements that can be translated to developing, drafting and validating test methods for container systems. The Engineer will apply these principles to system level characterization of component assemblies utilizing design control methodologies.
location: Exton, Pennsylvania
job type: Permanent
salary: $120,000 - 125,000 per year
work hours: 9 to 5
- Lead collaborations with internal and external team resources to develop new products, testing standards and technologies:
- Define deliverables, develop timelines, manage resources, and drive strategic projects to completion within budget and on time.
- Proactively interpret internal/external challenges and recommend best practices to improve products, processes and services that identify and understand customer/user needs and market requirements.
- Translate customer/user needs into design inputs/specifications of finally assembly container systems to design output.
- Lead and facilitate product development platforms that will transition new technologies to plant operations and provide ongoing support thru commercialization as applicable.
- Guide internal designers and external customers on products, processes to solve complex problems using analytical thinking, tools and judgement to identify innovative solutions
- Lead the efforts to develop, execute or sign off on design feasibility, design verification, and validation of test methods.
- Lead root cause investigations with moderate resources to completion.
- Prepare and present detailed technical reports, research posters/symposiums and applicable design documentation.
- Promote and carry out continuous research into relevant standards and guidance, testing and processing technology for sub-assembly components and final assembly container systems.
- Select, manage and leverage external consultants and laboratories when applicable to advance product concepts and research programs
- Provide subject matter expertise across the organization and ensure alignment with cross-functional stakeholders
- Work directly with customers to enable effective use of system level characterization work and to enable successful combination product filings
- Maintains a clean and tidy laboratory environment that is audit-ready at all times
- Lead and train other team members to accomplish plant and corporate goals while fostering global harmonization.
- Conform with and abide by all regulations, policies, work procedures, instruction, and all safety rules.
- Exhibit regular, reliable, punctual and predictable attendance.
- Perform all other duties as required.
- Education: Bachelor's in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or Materials Science. Masters or higher preferred.
- Experience: Minimum 8-10 years of work-related experience
- Recognized as an expert for sterility assurance testing of container systems in probabilistic (i.e. Vac/Pressure Decay, Dye Ingress) and deterministic (i.e. He Leak, HVLD) methodologies
- Must have effective problem solving and interpersonal skills.
- Proficient with design controls, product development, and test method development/validation.
- Working knowledge of applicable federal and international regulations such as ISO 13485 - Quality Management Systems for Medical Devices. 21CFR Parts 210, 211, and 820 a plus.
- Extended knowledge of 3D design applications (i.e. Solidworks) and statistical software such as Minitab.
- Six-sigma greenbelt or blackbelt a plus.
- Knowledge in Program Management Methodologies a plus
skills: Biomedical Engineering, Container Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.