Principal Engineer - Disposables R&D, Sustaining
 Spectraforce Technologies | |
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 May 07, 2025 | |
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Job Title: Principal Engineer - Disposables R&D, Sustaining * Serve as the technical expert for design change programs. (e.g. new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation). * Identify, investigate, and solve complex engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD). * Lead the creation and maintenance of design history files. * Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders. * Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance. * May supervise engineers and/or technicians. * May contribute to Baxter intellectual property through invention disclosures and patent applications. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. * Advanced knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization. * Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems. * Working knowledge of CAD design and PDM enterprise software (e.g. Creo, Solidworks). * Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices. * Creative Problem Solver - identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks. * Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements. * Ability to train and coach others from technical expertise. * Self-directed, resourceful, and able to manage multiple priorities. * Strong interpersonal, communication, collaboration and influencing skills. * Ability to read, write and comprehend English. Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred. * 5 - 8 years of related experience in Class II or Class III disposables medical product development. | |