R&D Sterile Disposables Senior Engineer (Microbiology & Biocompatibility) - Indianola, PA

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R&D Sterile Disposables Senior Engineer (Microbiology & Biocompatibility) - Indianola, PA

R&D Sterile Disposables Senior Engineer (Microbiology & Biocompatibility) Indianola, PA

PURPOSE

Responsible for the design, planning, execution, documentation, commissioning, and handover of specific technical work packages, ensuring they are completed on time and within budget. This role involves detailed engineering for a specific discipline, including the design, calculation, and specification of related engineering documents, as well as field engineering. The Project Engineer stays current with best practices and relevant internal and external regulations, implementing these standards throughout the project lifecycle.

The Senior Engineer supports the development, validation, and implementation of technical solutions for Radiology medical device programs, with emphasis on microbiology, chemistry, sterile disposable devices, and verification and validation testing. This role manages assigned technical work packages, applies established policies, procedures, regulations, and industry standards, and contributes to cross-functional project execution. The Senior Engineer works with moderate independence, escalates complex technical or strategic decisions as appropriate, and supports the technical direction established by Staff Engineers, management, and project leadership.

No Sponsorship is available for this position.

YOUR TASKS AND RESPONSIBILITIES

• Balance multiple concurrent projects, understand priorities of assigned tasks, and plan daily activities accordingly;
• Develop practical and creative solutions to challenging technical problems, with guidance for highly complex or novel issues;
• Support the development, integration, and maintenance of policies and procedures; write and apply relevant policies and procedures based on Federal Regulations, industry standards, and internal requirements;
• Apply knowledge of policies, procedures, regulations, and standards to develop, validate, and implement new or improved test methods;
• Apply appropriate tools and technologies to complex technical problems, including multidisciplinary activities, analytical evaluation, statistical analysis, and structured problem-solving techniques;
• Benchmark industry best practices and support the implementation of corrective and preventive actions;
• Align assigned R&D activities and technical deliverables with project priorities and strategy determined by management;
• Explain, train, and apply quality principles within assigned work areas and provide technical support for microbiology-related activities.

TECHNICAL SCOPE

• Support reprocessing of medical device compliance to global guidance documents and standards, including cleaning and disinfection validation;
• Conduct and/or support microbial ingress and simulated use testing for new product development and lifecycle management activities;
• Conduct and/or support chemical compatibility studies for new product development and lifecycle management activities;
• Conduct and/or support sub-visible particulate testing for new product development and lifecycle management activities, in accordance with global standards;
• Support ISO 10993-compliant biocompatibility and chemical characterization efforts as a preferred technical task, including coordination of testing, review of biological evaluation inputs, and collaboration with cross-functional stakeholders to support medical device compliance;
• Present findings and conclusions from data to R&D Program Management and cross-functional stakeholders;
• Coordinate…