Senior Device Development Engineer

Essential Duties and Responsibilities

• Executes combination product development projects on time, in scope, and within budget with responsibilities in project leadership, technical product engineering, design transfer, and/or secondary packaging
• Works closely with cross-functional team to assure project success
• Ensures that products being developed both internally and externally are technically robust through engineering analysis, ensuring that products perform sufficiently and reliably
• Identifies areas of project risk, escalates issues and risks in an expedient manner, and actively proposes solutions
• Assures work activities are conducted in a manner compliant with all applicable regulations and industry standards
• Maintains a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments
• Represents IOPS and the devices group at appropriate industry meetings and forums

Education and Experience

• Associate Engineer: Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field is required.
• Engineer: Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field and 2+ years of experience in product development or engineering is required or equivalent combination of education and experience. Experience in the medical device industry is preferred. Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 is preferred.
• Sr. Engineer: Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field and 5+ years of experience in product development or engineering is required or equivalent combination of education and experience. Experience in the medical device industry is required. Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 is required.