Senior Systems Engineer
Union City, CA, US, 94587-1234
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Job Duties: Mizuho Orthopedic Systems, Inc. in Union City, CA is seeking Senior Systems Engineer(s) to perform systems management and integration functions. Job responsibilities and duties include:
•Share and provide technical expertise and guidance to engineers and designers. •Lead projects and team with Product Release Testing, Verification and Validation Testing of Medical Devices as assigned. •Create innovative solutions to address user needs in products that differentiate the company in the market. •Translate customer needs into requirements and engineering specifications and document design input/output. •Meld technical contributors into a unified team and collaborate to determine best technologies for the product. •Develop, manage, and maintain design history files and related deliverables. •Develop, maintain, and execute to plans, milestones, schedules and task lists. •Manage and logically organize data to identify and describe problems and assess the suitability and quality of technical solutions. •Maintain up-to-date knowledge of medical devices, technologies, and regulatory landscape relate to the company’s products. •Perform complaint, failure and risk management activities plus develop mitigation and risk control strategies. •Perform engineering, integration, verification, and validation testing, including protocol development report generation and regression analysis. •Develop and document processes, methods, and tools for product testing and evaluation. •Support cross-functional design transfer process to ensure product designs manufacturable and serviceable. •Support product sustaining activities including value engineering, reliability improvements, manufacturability improvements, field issues with technical and impact analysis. •Manage, prioritize, and align work activities with project schedules. •Understand, follow, and support Mizuho OSI’s internal Quality System policies, procedures and instructions to include but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).
This position does not supervise any personnel or participate in any management decisions, nor does this position plan, direct or coordinate the activities of any personnel.
Minimum Requirements: Master’s degree in Engineering (Biomedical, Mechanical or Systems) or a related field of study, plus at least three (3) years of experience in the job offered or in any related position(s) in which the required experience was gained. In lieu of the above-stated primary education and experience requirements, employer will accept a Bachelor's degree in Engineering (Biomedical, Mechanical or Systems) or any related field of study and five (5) years of post-degree, progressively responsible experience in any related position(s) in which the required experience was gained. Qualified applicants must also have demonstrable proficiency, skill, experience, and knowledge with the following: 1. Develop Medical Devices in compliance with IEC 60601-1 2. VOC (Voice of Customer) and user needs collection and analysis 3. Understand clinical use environments and operating room surgical practices 4. Three years developing medical device in compliance with EU MDD and EU MDR and performing medical device risk management per ISO 14971 5. Two years with requirement and trace management for medical devices per ISO 13485 and 21 CFR Part 820; developing and maintaining DHFs (Design History Files) for medical devices per ISO 13485 and 21 CFR Part 820; and product release testing, verification and validation testing of medical devices per ISO 13485 and 21 CFR Part 820.
No Travel. Work from home benefit allowed within commuting distance of worksite.
Additional Information:
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