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

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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 with third-party testing laboratories, including possible on-site supervision of testing as needed; Develop, validate, and document test methods and procedures in support of R&D microbiology, chemistry studies, and biocompatibility.

ADDITIONAL RESPONSIBILITIES AND EXPERIENCE

Apply general understanding and proficiency of wet lab skills, including pipetting and dilution, aseptic technique, and safe biological handling; Culture microorganisms, including bacteria and bacteriophage, for testing and isolating or sub-culture microorganisms for identification; Perform testing on devices under simulated use conditions; Apply working knowledge of USP release testing for contrast media, including osmolality, particulate, pH, and chromatography for identification of organic impurities; Assist with specifying consumables, instruments, and equipment for R&D microbiology laboratory activities.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

Bachelors Degree in a scientific or engineering discipline, such as Microbiology, Chemistry, Biomedical Engineering, or a related field; 5 years of relevant experience within a technical discipline, with demonstrated depth in one or more technical specialties; Microbiology and laboratory knowledge with the ability to work across related technical disciplines; Demonstrated knowledge of Good Manufacturing Practices and Good Laboratory Practices; Demonstrated ability to analyze complex problems, synthesize practical solutions, and present technical information in a professional manner.

PREFERRED QUALIFICATIONS

Masters Degree in a scientific or engineering discipline; Experience supporting FDA and/or other regulatory body submissions, testing strategies, or Class II medical device product registrations; Practical knowledge of sterilization of medical devices; Practical knowledge of biocompatibility of medical devices; Practical knowledge of analytical and physical chemistry techniques and their application to medical device materials. Employees can expect to be paid a salary between $86,320.00 to $129,480.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This salary range is merely an estimate and may vary based on an applicants location, market data/ranges, an applicants skills and prior relevant experience, certain degrees and certifications, and other relevant factors. This posting will be available for application until at least 9-7-26. Location: United States : Pennsylvania : Indianola #J-18808-Ljbffr Bayer AG